Reported trial results for Primary Biliary Cholangitis

57 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

• NCT05239468 · results posted 16 July 2026

  According to the results reported on ClinicalTrials.gov, this trial enrolled 72 participants across four groups, all of whom had a liver condition being monitored through blood markers. Each group received a different combination of two medicines — obeticholic acid (OCA) or a placebo (inactive treatment), paired with either a lower or higher dose of bezafibrate (BZF). The main thing the trial was measuring was the change in a liver enzyme called alkaline phosphatase (ALP) — a substance in the blood that doctors use to monitor certain liver conditions — over a 12-week double-blind period (where neither participants nor researchers knew who was receiving which treatment). After the 12-week period, 67 participants moved into a longer follow-up phase lasting up to about three years, though the reported data shows that none had completed that longer phase at the time results were submitted. The reported data shows that all four groups had lower ALP levels at the end of the 12-week period compared to where they started, with the reductions ranging from about 87 units per litre (U/L) in the placebo plus lower-dose BZF group, to about 184 U/L in the OCA plus higher-dose BZF group. For the secondary measures, the reported data shows that the proportion of participants whose ALP dropped by at least 20% ranged from around 68% in the placebo plus lower-dose BZF group up to 100% in the placebo plus higher-dose BZF group. When looking at whether ALP returned to a normal range entirely, the reported figures ranged from about 5% in the placebo plus lower-dose BZF group to about 61% in the OCA plus higher-dose BZF group. Other liver markers in the blood — including GGT, ALT, AST, and bilirubin — were also measured, and the reported data shows reductions across all groups for most of these markers, with the largest reported reductions generally seen in the OCA plus higher-dose BZF group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04594694 · results posted 16 July 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT04594694) enrolled 75 adults across four treatment groups during its main double-blind phase (lasting up to three years). The four groups each received a different combination of two medicines: obeticholic acid (OCA) or a placebo, paired with one of two forms of bezafibrate (a lower-dose immediate-release version at 200 mg, or a higher-dose slow-release version at 400 mg). The trial was primarily measuring changes in a liver enzyme called alkaline phosphatase (ALP) — a substance in the blood that doctors use as a marker when monitoring certain liver conditions. A number of secondary measurements were also tracked, including other liver enzymes and bilirubin (a waste product processed by the liver). The reported data shows that all four groups had reductions in ALP levels from where they started. The group receiving placebo plus the lower-dose bezafibrate saw an average drop of around 111 units per litre (U/L), while the group receiving OCA plus the lower-dose bezafibrate saw a drop of around 114 U/L. The group on placebo plus the higher-dose bezafibrate saw a drop of around 137 U/L, and the group on OCA plus the higher-dose bezafibrate had the largest reported drop at around 184 U/L. For the secondary outcomes, the reported data shows that at the 12-week mark, between roughly 79% and 100% of participants across all groups had at least a 10% reduction in ALP from their starting level, depending on the group. The proportion of participants whose ALP returned to a normal range by week 12 ranged from about 21% in the placebo plus lower-dose group up to about 67% in the OCA plus higher-dose group. Changes in other liver markers — including GGT, ALT, AST, and bilirubin — were also reported across all groups, with varying degrees of change from baseline noted in each. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT06488911 · results posted 8 June 2026

  According to the results reported on ClinicalTrials.gov, this trial enrolled 62 participants, all of whom received a combination of two medicines: obeticholic acid (OCA) at 5 mg and bezafibrate (BZF) at 400 mg. The trial was measuring safety-related information — specifically, how many participants experienced unwanted medical events (called adverse events) while taking the combination, including any serious events or events that caused someone to stop taking the medicines. It is noted that none of the 62 participants were recorded as having "completed" the study, with all 62 listed under "not completed," which may reflect the trial ending early; no further explanation for this was provided in the reported data. The reported data shows that out of 62 participants, 29 experienced at least one treatment-emergent adverse event (that is, a new or worsening medical event that occurred after starting the medicines). Of those, 3 experienced a serious adverse event — meaning an event considered medically significant, such as one requiring hospitalisation — and 1 person stopped taking the medicines due to an adverse event. One participant experienced a severe adverse event, described as one causing an inability to carry out usual daily activities. No deaths were reported during the study. The reported data also shows changes in some blood test measurements (such as blood cell counts and chemical markers in the blood) from the start of the study to later time points, with varying numbers of participants showing notable shifts in individual measurements; however, the specific blood parameters linked to each number were not able to be individually matched from the data as submitted. The reported data shows no deaths among the 62 participants across any cause. For the blood test findings, some markers showed no notable changes while others were flagged for a small number of participants, but the full context and clinical meaning of those individual figures were not detailed in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05642468 · results posted 4 May 2026

  According to the results reported on ClinicalTrials.gov, this trial tested three different doses of an investigational drug called A3907 in a small number of participants: 8 people received 10 mg once daily, 6 received 30 mg once daily, and 4 received 30 mg twice daily (the twice-daily group also used something called a controlled-release system, or CRS). In total, 18 people started the trial, but only 10 completed it — 2, 3, and 3 people respectively did not finish in each group. The trial was primarily measuring how many participants experienced medical events (called adverse events) that arose after starting the drug, and it also tracked how the drug moved through the body and how certain blood and urine markers changed over 12 weeks. The reported data shows that, for the main measure — unwanted medical events during treatment — 5 out of 8 participants in the 10 mg once-daily group, 6 out of 6 in the 30 mg once-daily group, and 3 out of 4 in the twice-daily group experienced at least one such event. One participant in the 30 mg once-daily group experienced a serious adverse event; none were reported in the other two groups. For the body's absorption of the drug (measured as peak drug levels in the blood), the reported figures were 47.1, 142, and 78.3 nanograms per millilitre for the three groups respectively after a single dose, with similar patterns seen after repeated dosing — though figures for the twice-daily group after repeated doses were not reported. Changes in bile acid levels (substances in the blood and urine linked to liver function) and liver enzyme readings varied across the groups and in different directions, with some going up and some going down from where they started; the reported data shows these were small numerical changes, but the trial was not designed to draw firm conclusions from a group this size. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03710122 · results posted 22 April 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT03710122) enrolled 82 adults with a liver condition called primary sclerosing cholangitis (PSC) — 40 received oral vancomycin (an antibiotic taken by mouth) and 42 received a placebo (a dummy treatment). The trial ran for up to 24 months and was primarily measuring levels of a liver enzyme called alkaline phosphatase (ALP) in the blood — a marker that doctors monitor in people with this condition. Fewer participants remained in the trial over time: by the end of the 18-month treatment period, 15 in the vancomycin group and 20 in the placebo group were still taking part. The reported data shows the following average ALP levels (measured in units per litre, U/L) at each time point — vancomycin group first, placebo group second: at 6 months, 351 vs 355; at 12 months, 280 vs 354; at 18 months (end of treatment), 304 vs 311. The trial also measured ALP after treatment stopped — at 21 months, 349.5 vs 320.5; and at 24 months, 294.6 vs 262.4. No baseline (starting) ALP figures were included in the submitted results data, so a before-and-after comparison cannot be made from this data alone. For a secondary measure — the number of participants who showed a notable reduction in liver stiffness — the reported data shows 4 people in the vancomycin group and 2 in the placebo group met that threshold. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04480840 · results posted 23 January 2026

  According to the results reported on ClinicalTrials.gov, this trial tested an investigational drug called PLN-74809 across four different dose levels, compared against a placebo (a dummy treatment with no active ingredient). A total of 121 people took part — 30 in the placebo group and 91 across the four dose groups. The trial's main focus was on tracking unwanted medical events (called adverse events) that occurred or got worse after participants started taking the study drug or placebo. A secondary focus was measuring how much of the drug was present in participants' blood at certain time points. The reported data shows that, when it came to general adverse events, 21 out of 30 people in the placebo group experienced one, compared to 10, 16, 15, and 23 out of 24, 20, 20, and 27 people respectively across the four PLN-74809 dose groups. For serious adverse events — defined as events involving hospitalisation, life-threatening situations, lasting disability, or similarly significant medical concerns — one person each in the placebo group, dose level 1, dose level 2, and dose level 4 groups experienced one, while no one in dose level 3 did. Regarding blood levels of the drug two hours after a dose, the reported data shows higher concentrations at higher dose levels: approximately 639, 843, 2,036, and 3,668 nanograms per millilitre (a standard unit for measuring substance concentration in blood) at weeks 12 for the four dose groups respectively. Data at week 24 was only reported for the highest dose group, at around 3,584 nanograms per millilitre; figures for the other dose groups at that time point were not reported in the data. The trial also tracked a liver scarring (fibrosis) score called the ELF score — a blood test where a higher number indicates more severe disease. The reported data shows that at week 12, the average change from the starting score was +0.42 in the placebo group and ranged from +0.09 to +0.19 across the PLN-74809 dose groups. At week 24, only the placebo group (+0.14) and the highest dose group (+0.19) had data reported; figures for the other dose groups were not reported in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05525520 · results posted 31 July 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 62 people in total. For the first six weeks, 30 participants received a placebo (an inactive dummy tablet) followed by the study drug EP547, while 32 received EP547 throughout. The trial was mainly measuring changes in itch severity using a scoring tool called the Worst Itch Numeric Rating Scale (WI-NRS), where 0 means no itching and 10 means the worst itching imaginable. Several other itch-related questionnaires were also tracked as secondary measurements. The reported data shows that, over the first six weeks, the placebo group's average itch score dropped by 2.20 points from their starting score, while the group who received EP547 from the beginning saw a drop of 1.75 points. For a broader itch questionnaire (the 5-D Itch Scale, scored from 5 to 25, with higher scores meaning worse itch), both groups reported a similar reduction of around 3.7–3.8 points. When participants were asked to rate their overall impression of change in itch, about 55.6% of the placebo group and 60.7% of the EP547 group said their itch had at least minimally improved. When asked about itch severity category, 56.0% of the placebo group and 52.0% of the EP547 group reported moving to a less severe category. Around 44.4% of placebo participants and 35.7% of EP547 participants recorded a drop of at least 2 points on the itch scale, while 37.0% and 25.0% respectively recorded a drop of at least 3 points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04950127 · results posted 22 July 2025

  According to the results reported on ClinicalTrials.gov, this trial tested a medicine called linerixibat (40 mg) against a placebo (an inactive dummy treatment) in people with a condition that causes itching. The trial ran in two parts: Part A lasted 24 weeks, and Part B ran from week 24 to week 32. In Part A, 119 people were assigned to linerixibat and 119 to placebo. Participants rated their itching and sleep disruption on a scale of 0 to 10 (where 0 means none and 10 means the worst imaginable), and these scores were tracked over time. The reported data shows that, on average over the 24 weeks of Part A, itch scores fell by 2.86 points in the linerixibat group and by 2.15 points in the placebo group (both measured from each person's starting score). For sleep disruption scores, the average reduction over 24 weeks was 2.77 points in the linerixibat group and 2.24 points in the placebo group. At the two-week mark, itch scores had dropped by an average of 1.78 points in the linerixibat group compared to 1.07 points in the placebo group. The reported data also shows that by week 24, 68% of people taking linerixibat and 64% taking placebo had their monthly itch score drop by at least 2 points. When looking at a larger reduction of at least 3 points, 56% of the linerixibat group and 43% of the placebo group met that threshold. For an even larger drop of at least 4 points, the figures were 41% in the linerixibat group and 29% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02704364 · results posted 17 June 2025

  According to the results reported on ClinicalTrials.gov, this trial looked at a drug called NGM282 in people with a liver condition called Primary Sclerosing Cholangitis (PSC), which causes scarring of the bile ducts. A total of 62 people took part — 21 received a lower dose of NGM282 (1.0 mg), 21 received a higher dose (3.0 mg), and 20 received a placebo (a dummy treatment with no active ingredient). The trial mainly measured changes in a liver enzyme in the blood called alkaline phosphatase, which doctors often monitor in people with PSC. It also tracked several other liver-related substances in the blood. The reported data shows that for the main measure — the average change in alkaline phosphatase levels from the start of the trial — the 1.0 mg group saw an average increase of 25.6 units per litre, the 3.0 mg group saw an average decrease of 9.8 units per litre, and the placebo group saw an average decrease of 0.6 units per litre. In percentage terms, these changes were +7.1%, −4.2%, and −3.4% respectively. For two other liver enzymes (AST and ALT), the reported data shows the 3.0 mg group had larger average decreases compared to the 1.0 mg group and the placebo group, though the numbers varied across the two enzymes. For bilirubin (a substance that builds up when the liver is under stress), the 1.0 mg group showed a notable average increase, while the 3.0 mg and placebo groups showed only very small average changes. The rate-of-change data for alkaline phosphatase over time was only reported for the two NGM282 groups and was not reported for the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05014672 · results posted 24 April 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT05014672) enrolled 76 people in total — 24 in the setanaxib 1,200 mg/day group, 25 in the setanaxib 1,600 mg/day group, and 27 in the placebo group. The trial was measuring the effects of two different daily doses of a drug called setanaxib compared to a dummy (placebo) treatment in people with a liver condition called primary biliary cholangitis (PBC). The main thing being measured was a change in a liver enzyme called ALP (alkaline phosphatase) after 24 weeks. Several secondary measurements looked at fatigue and liver stiffness. Of the 76 who started, 60 completed the study — 17, 20, and 23 from each group respectively. The reported data shows that for the main outcome — ALP levels at 24 weeks compared to the start — the results were expressed as a ratio (where 1.0 would mean no change, below 1.0 means the level went down, and above 1.0 means it went up). The 1,200 mg group had a ratio of 0.89, the 1,600 mg group had a ratio of 0.84, and the placebo group had a ratio of 1.03. For liver stiffness (also expressed as a ratio), the reported figures were 0.78, 0.88, and 0.92 for the 1,200 mg, 1,600 mg, and placebo groups respectively. For fatigue, the trial used several different questionnaires. On one standardised fatigue scale (called a T-score, where a lower score means less fatigue), scores changed by −3.60, −0.80, and −1.43 in the three groups. On a separate 5-point fatigue severity scale (where lower is better), the changes were −0.07, +0.12, and +0.22. On a 7-point overall fatigue change scale (where lower scores mean more improvement), the groups scored 3.27, 3.62, and 3.58 respectively — all close to the "no change" midpoint of 4. On a quality-of-life fatigue questionnaire, scores changed by −1.44, −1.83, and −1.85 across the three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02609048 · results posted 25 February 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 41 people across three groups: 13 received seladelpar 200 mg, 14 received seladelpar 50 mg, and 14 received a placebo (an inactive dummy treatment). The trial was primarily measuring changes in a liver enzyme called alkaline phosphatase (AP) — a substance in the blood that doctors sometimes monitor in liver conditions. Only a small number of participants completed the full study: 2 in the 200 mg group, 4 in the 50 mg group, and 4 in the placebo group, meaning most participants did not finish. The reported data shows that, on average, AP levels fell by about 62.8% from their starting point in the 200 mg seladelpar group, and by about 53.2% in the 50 mg group. In the placebo group, AP levels changed by approximately −1.8% — meaning they stayed roughly the same. For a secondary measure looking at two liver markers together (AP and bilirubin, another substance tracked in liver health), the reported data shows that 100% of participants in the 200 mg group and 69.2% in the 50 mg group met a pre-set combined response target, compared with 8.3% in the placebo group. The trial also tracked other liver enzymes: AST and ALT levels were reported to have increased in both seladelpar groups (rising by roughly 233% and 131% for AST, and 181% and 112% for ALT, in the 200 mg and 50 mg groups respectively), while another enzyme called GGT was reported to have decreased by around 47% and 43% in those same groups. All of these markers stayed relatively unchanged in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05292872 · results posted 24 January 2025

  According to the results reported on ClinicalTrials.gov, this study looked at 4,577 people with a liver condition called primary biliary cholangitis (PBC). Of these, 403 were treated with a medicine called obeticholic acid (OCA), and 4,174 were treated with other approaches that did not include OCA. The study was observational — meaning it looked at real-world health records rather than randomly assigning people to treatments — and it tracked whether participants experienced serious liver-related events over time, including death from any cause, liver transplant, or hospital admission for certain liver complications. The reported data shows that, among the 403 OCA-treated participants, 8 experienced at least one of the serious events being tracked during the study period. Among the 4,174 non-OCA-treated participants, 32 such events were recorded. Breaking this down further: 2 deaths were recorded in the OCA group compared with 9 in the non-OCA group; 2 liver transplants occurred in the OCA group compared with 12 in the non-OCA group; and 6 hospitalisations for liver complications were recorded in the OCA group compared with 23 in the non-OCA group. It is important to note that the two groups were very different in size, so these raw numbers alone do not tell the full story — the study used a statistical method to try to make the groups more comparable before drawing conclusions, but the details of that analysis were not included in the figures submitted to the registry. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04024813 · results posted 16 January 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04024813) enrolled only one participant, who was assigned to receive a placebo (an inactive treatment used as a comparison). The trial was designed to study a condition called Primary Sclerosing Cholangitis (PSC), a disease affecting the liver's bile ducts. The main thing the trial set out to measure was a change in a liver-related blood marker (called alkaline phosphatase) after 24 weeks, along with several other measures such as disease-related symptoms, liver disease progression, and any unwanted health events experienced by participants. The reported data shows that the single participant did not complete the study, and the trial was ended early. Because of this, the primary outcome — the change in the blood marker at 24 weeks — was not reported, as no data was collected for it. For one of the secondary outcomes, which tracked any unwanted health events (called treatment-emergent adverse events) up to Day 59, the reported number was zero, meaning no such events were recorded for that participant. The remaining secondary outcomes, covering PSC-related symptoms or procedures and liver disease progression events, also had no data reported. It is worth noting that with only one participant and an early termination, the reported data is extremely limited and does not allow for any meaningful conclusions about the treatment being studied. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03112681 · results posted 19 September 2024

  According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called saroglitazar magnesium in people with a liver condition called primary biliary cholangitis. A total of 37 people took part — 14 received the 2 mg dose, 13 received the 4 mg dose, and 10 received a placebo (a dummy treatment with no active ingredient). The trial ran for 16 weeks. By the end, 13, 10, and 9 people in each of those three groups respectively had completed the study. The main thing the trial was measuring was the change in a substance in the blood called alkaline phosphatase (ALP) — a marker that doctors use to monitor liver conditions. The reported data shows that, after 16 weeks, the average ALP level fell by approximately 164 units per litre (U/L) in the 2 mg group, by approximately 162 U/L in the 4 mg group, and by approximately 11 U/L in the placebo group. These are the average changes within each group as reported; no other outcome measures were included in the data submitted to ClinicalTrials.gov for this trial. It is worth noting that this was a relatively small trial with fewer than 40 participants across all three groups, and only one outcome measure was reported in the submitted data. No secondary outcome measure data was provided, so those results are not available to describe here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04526665 · results posted 5 September 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04526665) enrolled 161 people with primary biliary cholangitis (PBC), a liver condition. Of these, 108 were assigned to take elafibranor 80 mg daily and 53 received a placebo (a dummy tablet with no active ingredient). The trial ran for 52 weeks. It was measuring changes in certain liver-related blood markers — mainly a substance called alkaline phosphatase (ALP) and total bilirubin — to see how many participants reached pre-set target levels by the end of the year. Around 94 people in the elafibranor group and 46 in the placebo group completed the full study period. The reported data shows that for the main outcome — reaching a combined target for ALP and bilirubin blood levels at 52 weeks — about 50.9% of participants in the elafibranor group met that target, compared with 3.8% in the placebo group. For a stricter measure (ALP returning fully to the normal range), the reported figures were 14.8% in the elafibranor group and 0% in the placebo group. The trial also measured itching (a common symptom in PBC) in participants who had moderate-to-severe itch at the start, using an 11-point self-rated scale (0 = no itch, 10 = worst imaginable). The reported data shows average itch scores fell by 1.93 points in the elafibranor group and 1.15 points in the placebo group by week 52. In terms of ALP blood levels (measured in units per litre), the reported average reduction at 52 weeks was approximately 118 units/L in the elafibranor group compared with approximately 9 units/L in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03545672 · results posted 9 August 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people with a liver condition called primary biliary cholangitis (PBC) and 59 people without the condition who acted as a comparison (control) group. The trial was looking at whether people with PBC showed any differences in heart-related measurements compared to healthy controls. A small number of participants did not finish the study — four in the PBC group and three in the control group — leaving 56 completers in each group. The reported data shows two main things were measured. First, the trial tracked whether participants experienced serious heart events — specifically, cardiac death, heart attack, or hospitalisation for unstable chest pain. According to the results reported on ClinicalTrials.gov, the number recorded for each of these events was zero in both groups, meaning none of these events were reported during the follow-up period. Second, the trial used a special heart scan technique called T1 mapping to estimate the amount of a substance called "extracellular volume" (ECV) in the heart muscle — essentially, a way of measuring changes in the heart's tissue structure. The reported data shows the PBC group had an average ECV of 30%, compared to 26% in the control group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04620733 · results posted 25 July 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04620733) looked at a medicine called seladelpar compared to a placebo (a dummy treatment with no active ingredient) in 193 people in total — 65 received the placebo and 128 received seladelpar. The trial was measuring two main things: whether certain liver-related blood markers reached target levels after 12 months, and what unwanted events or changes in blood tests were recorded during the study. It also looked at changes in itching scores as a secondary measure. The reported data shows that for the main blood marker goal at 12 months — which required three specific liver-related values to all reach certain target levels at the same time — 20% of people in the placebo group and 61.7% of people in the seladelpar group met that combined target. For a separate secondary target where one of those markers (called ALP, a liver enzyme) returned completely to the normal range, 0% of the placebo group and 25% of the seladelpar group reached that level. Regarding unwanted events during the study, 84.6% of the placebo group and 86.7% of the seladelpar group reported at least one treatment-emergent adverse event (that is, any unwanted medical event that happened after starting the study treatment); serious adverse events were reported in 6.2% of the placebo group and 7.0% of the seladelpar group. Notable shifts in blood test results (a worsening of at least two severity grades from starting levels) were seen in 12.3% of the placebo group and 14.1% of the seladelpar group for blood and liver-related tests combined. The reported data also shows that among participants who had a meaningful level of itching at the start, the average itching score (on a 0–10 scale, where 0 is no itch and 10 is the worst imaginable) changed by −1.7 points in the placebo group and −3.2 points in the seladelpar group at six months, meaning both groups reported lower itching scores than at the beginning, with the seladelpar group reporting a larger reduction on average. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04604652 · results posted 24 April 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04604652) enrolled 24 adult participants, all of whom completed the study — none dropped out. All participants had a liver condition called primary biliary cholangitis (PBC) and had not responded well enough to their standard treatment. Every participant received the same investigational medicine, HTD1801, at a dose of 1,000 mg twice daily for 12 weeks. The trial was measuring changes in several blood markers — substances that doctors use to monitor liver and immune system activity — comparing levels at the start of the study to levels after 12 weeks. The reported data shows the following changes from the start of the study to week 12. The main thing being measured was a liver enzyme called alkaline phosphatase (ALP): the reported average change was a reduction of 7.7%. For the additional measures, total bilirubin (a substance that can build up when the liver is under stress) fell by an average of 0.10 mg/dL; a liver enzyme called GGT fell by an average of 34.1 U/L; total cholesterol fell by an average of 18.8 mg/dL; and an immune-system protein called IgM fell by an average of 36.8 mg/dL. Finally, something called the GLOBE score — a calculated risk tool used in PBC — fell by an average of 0.07 points. The reported data notes that reductions in these markers are generally considered to point in a favourable direction, but this trial alone does not establish what these changes mean for longer-term health outcomes. It is worth noting that this was a small, single-group study with no comparison group receiving a different or dummy treatment, which limits how the numbers can be interpreted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03890120 · results posted 29 November 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT03890120) looked at a drug called cilofexor (100 mg) compared to a placebo (a dummy tablet with no active ingredient) in people with liver disease. A total of 419 people took part in the main blinded phase — 278 received cilofexor and 141 received placebo — over roughly two years (about 100 weeks). Neither the participants nor the researchers knew who was getting which treatment during this phase. A smaller follow-on open-label extension phase (where everyone knew they were receiving cilofexor) then ran for about 45 weeks, involving 80 participants who had previously taken cilofexor and 45 who had previously taken placebo. The reported data shows that the main thing being measured was whether participants' liver scarring (called fibrosis) got worse over the two-year period. Scarring was rated on a scale of 0 (no scarring) to 4 (severe scarring, known as cirrhosis), and "getting worse" meant moving up at least one step on that scale. According to the results reported on ClinicalTrials.gov, 30.8% of people in the cilofexor group and 32.8% of people in the placebo group showed this worsening — meaning roughly 3 in 10 people in each group had an increase in their liver scarring score. The reported data also shows that a blood marker linked to liver and bile duct function (called alkaline phosphatase, or ALP) changed by an average of 0 units per litre in the cilofexor group and 3 units per litre in the placebo group at the end of the main phase. The reported data also recorded how many participants experienced unwanted medical events (called adverse events) during the trial. In the blinded phase, 97.1% of the cilofexor group and 95.0% of the placebo group reported at least one such event. Serious adverse events — defined as those involving hospitalisation, life-threatening situations, death, or significant disability — were reported in 19.1% of the cilofexor group and 18.7% of the placebo group during the blinded phase. In the open-label extension phase, 66.3% of those who had been on cilofexor throughout and 73.3% of those who had switched from placebo reported an adverse event, while serious adverse events were reported in 11.3% and 2.2% of those groups respectively. It is important to note that these figures describe events that happened during the trial period and do not on their own tell us whether the drug caused them. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04060147 · results posted 27 July 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 11 participants who all received the study drug cilofexor. Ten of the 11 participants completed the trial, and one did not finish. The trial was measuring how often participants experienced unwanted medical events (called adverse events) while taking the drug, including both general side effects and more serious ones, as well as any notable changes in their laboratory test results. The reported data shows that 81.8% of participants (roughly 9 out of 11) experienced at least one treatment-emergent adverse event — meaning an unwanted medical event that occurred during or shortly after taking the study drug. No participants (0%) experienced a serious adverse event, which the trial defined as events such as hospitalisation, life-threatening situations, or death. Regarding laboratory test abnormalities — unexpected changes in blood or other test results compared to the start of the trial — the reported data shows 54.5% of participants had mild changes, 36.4% had moderate changes, 9.1% had severe changes, and 0% had life-threatening changes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02308111 · results posted 9 March 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT02308111) enrolled 168 people who received obeticholic acid (OCA) and 166 people who received a placebo (a dummy treatment), all of whom also received standard local care for primary biliary cholangitis (PBC), a chronic liver condition. The trial was measuring how long it took for serious liver-related events to occur — such as death, needing a liver transplant, or the liver becoming severely damaged — comparing the two groups over time. The reported data shows that none of the participants were recorded as having "completed" the trial in the usual sense, meaning all participants either left the study early or the trial was stopped before a scheduled end point was reached. The reported data shows results for several measured outcomes, all expressed as the number of days until a key event first occurred (using a statistical method called Kaplan-Meier, which estimates how long it takes for a certain proportion of participants to reach an event). For the main combined outcome — covering death, transplant, or severe liver complications — the reported 25th percentile (meaning the point at which one-quarter of participants had experienced an event) was 1,092 days in the OCA group and 970 days in the placebo group; the 50th percentile (halfway point) was not reached in either group, meaning fewer than half of participants experienced that event during the study period. For a broader version of this combined outcome, the 25th percentile was 370 days for OCA and 450 days for placebo, while the 50th percentile was 1,827 days for OCA and 1,102 days for placebo. For the outcome of liver transplant or death from any cause, the 25th percentile was 1,580 days for OCA and 1,803 days for placebo; the 50th percentile was not reported for either group. For liver transplant alone, the reported proportion of participants who received a transplant by five years was 0.18 (about 18%) in the OCA group and 0.16 (about 16%) in the placebo group. For the outcome of death from any cause, no data points were reported for either group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03394781 · results posted 17 October 2022

  According to the results reported on ClinicalTrials.gov, this trial enrolled a total of five people — three in a group receiving a 10 mg dose of a study drug called DUR-928, and two in a group receiving a 50 mg dose. All five participants completed the trial; none dropped out. The trial was measuring changes in certain liver-related substances in the blood — mainly a liver enzyme called alkaline phosphatase (ALP), along with other liver enzymes and bile acids (natural substances made by the liver) — to see how those levels shifted from the start of the trial to the end of treatment and a follow-up period. The reported data shows that, for the primary measurement (change in ALP levels), the 10 mg group had reported changes of around 23.7% and 10.7% at different time points, while the 50 mg group had reported changes of around 16.8% and 11.05%. For the secondary measurements covering other liver enzymes and bile acids, the reported figures varied quite a bit between the two groups and across different time points — for example, one bile acid measure showed a reported change of approximately −13.9% in the 10 mg group and −44.1% in the 50 mg group (a negative number here means a reduction from baseline). The reported data shows that no participants in either group were recorded as having a reduction in ALP that met the threshold being tracked in one of the secondary measures. For the final secondary outcome — changes in selected biomarkers (biological markers measured in the blood) — no data was reported. It is worth noting that with only five participants in total, this was a very small trial, and the numbers above simply describe what was recorded and submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03633227 · results posted 6 September 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03633227) enrolled 22 children and young people in total — 12 in the placebo group and 10 in the obeticholic acid (OCA) group — during the first phase of the study, which ran up to 48 weeks. The trial was primarily measuring how the body absorbed and processed OCA, a medicine being investigated for a liver condition. Specifically, researchers tracked how much of the drug reached the bloodstream, how quickly it peaked, and how long it stayed in the body. Relatively few participants completed the full double-blind phase (4 in the placebo group and 6 in the OCA group), and none completed the longer extension phase that was intended to run up to three years. The reported data shows results mainly for participants taking OCA at a dose of 5 mg once weekly. At week 12, the peak amount of the drug measured in the blood (called Cmax) was reported as 293 nanograms per millilitre, and the time it took to reach that peak (Tmax) was about 2 hours. The lowest level measured in the blood over a 24-hour period (Ctrough) was 77.6 nanograms per millilitre, and the total exposure to the drug over 24 hours (a measure called AUC) was 2,970 nanogram-hours per millilitre. By week 18, figures were also available for a twice-weekly 5 mg dose group: the peak blood level was 136 ng/mL for the once-weekly group and 406 ng/mL for the twice-weekly group, with peak times of 0.75 hours and 2.52 hours respectively. No data were reported for the 10 mg twice-weekly dose group at either time point, and the results data did not include figures for the placebo group for these measurements. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03602560 · results posted 31 May 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03602560) looked at a medicine called seladelpar in people with a liver condition. A total of 265 people took part — 89 in a group that started on a lower dose of seladelpar (5 mg) and could move up to a higher dose (10 mg), 89 in a fixed higher-dose group (10 mg), and 87 in a placebo group (a dummy treatment with no active medicine). The trial was measuring whether seladelpar could hit a combination target related to a liver enzyme called alkaline phosphatase (ALP) and another liver marker called total bilirubin, checked at three months. The reported data shows that for the main combined target at three months, 32 out of 89 participants in the 5–10 mg group, 43 out of 89 in the 10 mg group, and 7 out of 87 in the placebo group met the criteria. For one of the secondary measures — whether ALP levels returned to within the normal range — the reported numbers were 3 out of 89 in the 5–10 mg group, 15 out of 89 in the 10 mg group, and 0 out of 87 in the placebo group. The trial also measured itching (rated on a 0–10 scale, where 0 means no itch and 10 means the worst imaginable) among participants who reported moderate-to-severe itching at the start. The reported average change in itch score from the start of the trial to three months was −1.95 points in the 5–10 mg group, −3.01 points in the 10 mg group, and −1.44 points in the placebo group (negative numbers indicate a reduction in reported itching). It is worth noting that the reported data shows only 1 participant in each group was recorded as having completed the study, with the large majority listed as "not completed" — the reasons for this were not detailed in the data provided on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03333928 · results posted 6 April 2022

  According to the results reported on ClinicalTrials.gov, this trial tested an investigational medicine called HTD1801 in people with a liver condition. Participants were split into three groups: one taking a lower dose of HTD1801 (500 mg twice daily), one taking a higher dose (1,000 mg twice daily), and one taking a placebo (a dummy treatment with no active ingredient). The trial ran in three back-to-back periods. In the first period, 16, 25, and 18 people started in each group respectively. The trial was primarily measuring changes in a liver enzyme in the blood called alkaline phosphatase (ALP) — a substance doctors sometimes monitor as a marker of liver stress — over the first six weeks. The reported data shows that after six weeks (Period 1), average ALP levels fell by 71 units per litre (U/L) in the lower-dose group and by 73 U/L in the higher-dose group, while the placebo group's average ALP level rose by 94 U/L. For the secondary measures during this same six-week period: the number of participants whose ALP dropped to below 1.5 times the upper limit of the normal range was 2 (lower dose), 6 (higher dose), and 1 (placebo). The number who achieved a 50% drop in ALP was 1, 4, and 0 respectively, and the number whose ALP returned fully to the normal range was 0, 2, and 0. Average total bilirubin (another liver-related blood marker) changed by −0.2, 0.0, and +0.1 mg/dL across the three groups. In the second six-week period, participants who had been on placebo and switched to the higher dose showed an average ALP drop of 189 U/L, while other subgroups showed smaller or no notable changes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03155932 · results posted 24 March 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03155932) enrolled 2 participants who were given a study drug called APD334 (also known as etrasimod). The trial was designed to look at two main things: changes in a blood marker called alkaline phosphatase (ALP) — a substance that, when elevated, can suggest a liver condition is progressing — and the number of participants who experienced any unwanted or unexpected health events (called adverse events) during the study. Both participants started the trial, both moved on to a higher dose at the 12-week mark, and both completed the study. The reported data shows that for the ALP blood marker measurements — one of the primary things the trial set out to measure — no numerical results were submitted to ClinicalTrials.gov, so those figures are not available. For the second primary measure, the reported data shows that 2 out of 2 participants experienced at least one adverse event. No numbers were reported for the secondary outcomes, which included further ALP measurements and an assessment of how the drug moved through the body (known as pharmacokinetics). The exploratory outcomes, such as changes in blood counts and fatigue levels, also had no data reported. It is worth noting that with only 2 participants, this was an extremely small study, and the absence of many reported numbers means there is very limited information available from this trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03359174 · results posted 9 August 2021

  According to the results reported on ClinicalTrials.gov, this trial looked at a treatment called All-trans Retinoic Acid (ATRA) in people with a liver condition. The trial set out to measure changes in certain blood markers — including a liver enzyme called alkaline phosphatase (ALP), bile acids, and other indicators of liver health — by comparing blood test results before and after treatment. Only 2 people enrolled in the trial, 1 of whom completed it and 1 of whom did not finish. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures — neither the primary measure (change in ALP levels) nor any of the six secondary measures (such as changes in bile acids, liver enzymes, or a liver scarring score). Because no measurement data was reported, it is not possible to describe what the blood tests showed for either participant. Given the very small number of participants and the absence of any reported numerical results, the data as submitted does not allow any conclusions to be drawn about the outcomes being studied. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03722576 · results posted 2 June 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03722576) enrolled 18 people, all of whom received a treatment called vidofludimus calcium. Eleven participants completed the study, while seven did not finish. The trial was looking at changes in certain liver-related blood markers — specifically alkaline phosphatase (ALP, an enzyme linked to liver and bone activity) and aspartate aminotransferase (AST, an enzyme linked to liver and muscle cells) — to see how levels of these substances changed over 24 weeks. The reported data shows that for the main (primary) outcome, 3 out of the 18 participants met the combined target: a drop of 25% or more in their ALP levels alongside an increase of no more than 33% in their AST levels at the 24-week mark. For the secondary outcomes, the reported data shows that 8 participants had AST levels outside the normal range, and 8 participants had ALT levels (another liver enzyme) outside the normal range. Three participants had total bilirubin levels (a pigment processed by the liver) outside the normal range, and 4 participants had direct bilirubin levels outside the normal range. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03394924 · results posted 18 May 2021

  According to the results reported on ClinicalTrials.gov, this trial tested two doses of an investigational drug called EDP-305 (1 mg and 2.5 mg) against a placebo (an inactive treatment) in 68 people in total — 31 in the 1 mg group, 28 in the 2.5 mg group, and 9 in the placebo group. The trial ran for 12 weeks and was primarily measuring whether participants' blood levels of a liver enzyme called alkaline phosphatase (ALP) — a marker sometimes monitored in liver conditions — dropped by at least 20%, or returned to a normal range, by the end of the study. The reported data shows that 45.2% of participants in the 1 mg group and 46.4% in the 2.5 mg group met that ALP target, compared with 11.1% in the placebo group. For the secondary outcomes, the trial also tracked unwanted medical events (called adverse events) that occurred during treatment. According to the results reported on ClinicalTrials.gov, 71.0% of the 1 mg group, 89.3% of the 2.5 mg group, and 88.9% of the placebo group experienced at least one such event during the study period. Serious adverse events (those considered medically significant, such as requiring hospitalisation) were reported in 3.2% of the 1 mg group, 7.1% of the 2.5 mg group, and 0% of the placebo group. The reported data also shows that 3.2% of the 1 mg group and 17.9% of the 2.5 mg group stopped taking the study treatment because of an adverse event, compared with 0% in the placebo group. The trial also measured changes in several other liver-related blood markers (including ALT, AST, GGT, and bilirubin) from the start to the end of the 12 weeks. The reported data shows varying degrees of change across the groups for each of these markers, though a full breakdown of what each individual number means in a clinical context was not provided in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02966834 · results posted 4 May 2021

  According to the results reported on ClinicalTrials.gov, this trial enrolled 147 people in total across six groups. Participants had primary biliary cholangitis (PBC), a liver condition, and were experiencing itching. The trial was measuring whether different doses of a medicine called GSK2330672 — taken either once or twice a day — changed the severity of itching compared to a dummy treatment (placebo) over roughly 16 weeks. The study also looked at certain liver-related markers in the blood, and at participants' quality of life using a standardised questionnaire. The reported data shows that, for the main outcome — change in worst daily itch score on a 0–10 scale — all groups reported a reduction in their itch score from their starting point. The placebo group reported an average reduction of 1.73 points. The five GSK2330672 dose groups reported average reductions ranging from 2.19 points (20 mg once daily) to 2.86 points (40 mg twice daily). For the quality-of-life questionnaire focused on itch (scored 3–15, where higher means worse), the placebo group reported a change of −2.3 points, while GSK2330672 groups reported changes ranging from −1.9 to −3.4 points. For blood markers related to liver health (ALP, ALT, and AST), the reported changes varied across the dose groups, with some groups showing decreases and others showing increases from their starting values; the reported data does not allow a straightforward pattern to be drawn across all doses. Only one participant (in the 90 mg twice-daily group) met the specific threshold for a favourable liver marker response at Week 16. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00059202 · results posted 8 April 2021

  According to the results reported on ClinicalTrials.gov, this trial enrolled 150 people — 76 in the ursodeoxycholic acid (a bile acid medication) group and 74 in the placebo (inactive treatment) group. The trial was studying a liver condition called primary sclerosing cholangitis over up to five years. The main thing researchers were tracking was "treatment failure," which they defined as a combination of serious events: death, needing a liver transplant, reaching a threshold of liver disease severity that qualifies someone for transplant listing, developing enlarged blood vessels in the oesophagus or stomach (varices), developing a type of bile duct cancer (cholangiocarcinoma), or the liver disease progressing to cirrhosis (severe scarring). The reported data shows that, for the main outcome, 30 out of 76 people (about 39%) in the ursodeoxycholic acid group experienced one of these treatment failure events, compared with 19 out of 74 people (about 26%) in the placebo group. For the individual secondary outcomes tracked over up to five years: 5 deaths were reported in the medication group versus 3 in the placebo group; 11 people in the medication group received a liver transplant compared with 5 in the placebo group; 13 versus 10 participants reached the transplant-listing disease severity threshold; 2 versus 2 developed bile duct cancer; and 15 versus 5 developed varices. The reported data does not include a breakdown of how many participants progressed to cirrhosis separately from the other events. It is worth noting that more people in the placebo group did not complete the study (15 people) compared with the medication group (6 people), which the reported data does not explain further. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03742973 · results posted 14 October 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT03742973) was studying baricitinib compared to a placebo (an inactive treatment) in people with a liver condition. The trial was organised into groups — a "Baricitinib Cohort A" and a "Placebo Cohort A." The study was measuring things like changes in a liver enzyme called Alkaline Phosphatase (ALP, a substance in the blood that can indicate liver health), as well as participant-reported scores for itching and fatigue on simple 0–10 rating scales, where 0 means no symptoms and 10 means the worst imaginable. The reported data shows that no participant numbers were recorded for either group — the number who started, completed, or did not complete the study was listed as zero for all groups. Alongside this, no numerical results were submitted for any of the outcome measures, including the primary measure (change in ALP levels) or any of the secondary measures (the proportion of participants reaching a certain ALP target, changes in itch scores, or changes in fatigue scores). In other words, the data for all measured outcomes was not reported in the structured results submitted to ClinicalTrials.gov. Because no results data appears to have been submitted, it is not possible to describe what the trial found about any of its measurements. If you are interested in this trial or this treatment area, the absence of reported data here means this particular submission does not provide information to draw on. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04053023 · results posted 24 July 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT04053023) enrolled 19 participants in Part A, all of whom started the study. The trial was measuring how two medicines — obeticholic acid (OCA) and linerixibat — interact in the body when taken together, compared to OCA taken alone. Specifically, it tracked how much of the drug OCA was absorbed into the bloodstream and how high the drug levels peaked, using blood samples collected at set time points. The reported data shows that Part B of the trial had no participants enrolled, so only Part A results are available. The reported data shows that when participants took OCA 10 mg on its own, the total amount of OCA measured in the blood over time (a measure called "area under the curve," which is simply a way of capturing how much drug was in the body and for how long) was reported as approximately 2,330 and 2,350 units (hours × nanograms per millilitre) across two slightly different calculation methods. When OCA was taken together with linerixibat 90 mg, those same figures were reported as approximately 783 and 787 units — noticeably lower numbers. The peak blood level of OCA (the highest concentration reached) was reported as approximately 206 nanograms per millilitre when taking OCA alone, compared with approximately 83 nanograms per millilitre when taking OCA alongside linerixibat. No outcome data for Part B was reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02078882 · results posted 30 March 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 16 participants, all of whom received weekly injections of a medicine called abatacept (125 mg). All 16 participants completed the study — none dropped out. The trial was looking at a condition affecting the liver called primary biliary cholangitis, and the main thing researchers were measuring was whether a particular liver enzyme called alkaline phosphatase (a substance in the blood that can signal liver stress) dropped by more than 40% after 24 weeks of treatment. The reported data shows that only 1 out of the 16 participants met that main target — meaning their alkaline phosphatase level fell by more than 40% from where it started. On average across all participants, the alkaline phosphatase level changed by minus 2.8 units (IU/L) over 24 weeks, which the data presents as a very small decrease. Another liver enzyme called ALT showed an average change of plus 0.5 units (IU/L) — essentially little change. A scan-based measure of liver stiffness (how firm the liver tissue is, measured using a special type of MRI) showed an average change of minus 0.1 kPa, again a very small shift. A quality-of-life questionnaire designed specifically for this liver condition showed an average change of zero — meaning no overall change was recorded in participants' reported quality of life. Regarding safety, the reported data shows that 4 out of 16 participants experienced some form of adverse event (an unwanted or unexpected health occurrence) during the study, though further detail on the nature of those events was not included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02978339 · results posted 18 January 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 15 participants, all of whom completed the study — none dropped out. The trial was looking at curcumin (a compound found in turmeric) in people with a liver condition called Primary Sclerosing Cholangitis (PSC). The main thing researchers were tracking was whether a specific liver enzyme in the blood — called Serum Alkaline Phosphatase (SAP) — dropped to a certain level over 12 weeks. They also tracked several other blood markers and how tired participants felt. The reported data shows that out of the 15 participants, 3 met the target for a meaningful reduction in the SAP liver enzyme by week 12. For the secondary measures, the reported average figures at the end of the study were: an AST enzyme level (another liver marker, normally 10–40 units per litre) of 78 units per litre; a total bilirubin level (a pigment the liver processes, normally 0.3–1.9 mg/dL) of 0.6 mg/dL; a C-reactive protein level (a marker linked to inflammation, normally below 3.0 mg/L) of 3.4 mg/L; and a Mayo PSC Risk Score (a combined score used to track disease progression) of 0.54. Fatigue, measured on a scale of 0 to 84 where higher numbers mean greater fatigue, was reported at an average score of 8. It is worth noting that these figures appear to represent values at a single point in time rather than the change from the start of the study, and no comparison group (such as a placebo group) was included in this trial. The reported data does not allow conclusions about whether curcumin caused any of these results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02943447 · results posted 13 January 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 71 adults in total across three groups: 28 people received cilofexor 100 mg, 30 received cilofexor 30 mg, and 13 received a placebo (an inactive treatment used for comparison). The trial had two phases — a blinded phase (where participants did not know which treatment they were receiving) and an open-label extension phase (where all participants received active treatment and knew what they were taking). The trial was primarily measuring how often participants experienced unwanted medical events (called adverse events) and abnormal laboratory test results during both phases. The reported data shows that during the blinded phase, unwanted medical events were recorded in 89.3% of participants in the cilofexor 100 mg group, 76.7% in the cilofexor 30 mg group, and 84.6% in the placebo group. Serious unwanted medical events during this phase were reported in 0% of the 100 mg group, 3.3% of the 30 mg group, and 0% of the placebo group. Abnormal laboratory results were recorded in 85.7% of the 100 mg group, 86.7% of the 30 mg group, and 92.3% of the placebo group, with no serious laboratory abnormalities reported in the 100 mg or placebo groups, and 3.3% in the 30 mg group. During the open-label extension phase, unwanted medical events were reported in 95.7%, 89.3%, and 100% of participants from the original 100 mg, 30 mg, and placebo groups respectively, with serious events reported in 4.3% of those from the 100 mg group and none from the other two groups. Abnormal laboratory results in the extension phase were reported in 91.3%, 96.4%, and 100% across the three groups, with no serious laboratory abnormalities recorded in any group during this phase. It is worth noting that the open-label extension phase had a high number of participants who did not complete it — 18 of 23 from the 100 mg group, 25 of 28 from the 30 mg group, and 10 of 12 from the placebo group — though the reasons for this were not detailed in the data provided here. Any figures not listed above were not reported in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02516605 · results posted 13 November 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02516605) enrolled 61 people in total across five groups. Four groups received different daily doses of a drug called LJN452 (0.03 mg, 0.06 mg, 0.09 mg, or 0.15 mg once a day), while a fifth group received a placebo (a dummy treatment with no active ingredient). The trial ran for 28 days and measured several things: a liver enzyme in the blood called GGT (gamma-glutamyl transferase, a marker that can reflect liver activity), as well as general body monitoring readings such as blood pressure, pulse rate, body temperature, and heart-related electrical readings (ECGs). Almost all participants who started the trial completed it — only one person in the 0.15 mg group and one in the placebo group did not finish. The reported data shows that for the main liver enzyme measurement (GGT), the numbers are expressed as a "fold change" — meaning how much the level multiplied or shrank compared to where it started, with a value below 1.0 indicating the level was lower at Day 28 than at the beginning. The placebo group had a reported fold change of 0.86, while the four LJN452 dose groups had reported fold changes of 0.74 (0.03 mg), 0.41 (0.06 mg), 0.28 (0.09 mg), and 0.31 (0.15 mg). For the monitoring readings, the reported data shows blood pressure readings across time points ranging roughly from 118 to 132 mmHg across all groups, pulse rates ranging from about 61 to 75 beats per minute, body temperatures all close to 36.4–36.7°C, and ECG heart rate and interval readings that were broadly similar across groups. The data as submitted includes multiple time-point readings for some of these measures, but the trial record does not provide a complete breakdown of which reading belongs to which specific time point for all groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01672853 · results posted 22 October 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 235 people across three groups: 79 received a lower dose of a medicine called SIM at 75 mg, 77 received a higher dose of SIM at 125 mg, and 79 received a placebo (a dummy treatment with no active ingredient). The trial ran for about 96 weeks and was primarily measuring changes in something called MQC (a marker assessed from a liver biopsy — a small tissue sample taken from the liver) to see whether levels changed over time in each group. The reported data shows that, for the main outcome — change in MQC levels in liver tissue from the start of the trial to week 96 — the average change was −0.5 percentage points in the SIM 75 mg group, +0.5 percentage points in the SIM 125 mg group, and 0.0 percentage points in the placebo group. In other words, all three groups showed very little change from their starting levels. The reported data also shows that the percentage of participants who permanently stopped taking their study medication due to an unwanted side effect was 5.1% in the SIM 75 mg group, 7.8% in the SIM 125 mg group, and 10.3% in the placebo group. On average, participants were exposed to their study treatment for approximately 92 weeks (SIM 75 mg), 83.8 weeks (SIM 125 mg), and 87.4 weeks (placebo). The reported data also shows that laboratory test abnormalities — unexpected changes picked up in blood or other tests — were recorded across all three groups at various severity levels (mild, moderate, severe, and life-threatening), with figures ranging roughly from 7% to 49% of participants depending on the severity category and group. These figures were broadly similar across the SIM and placebo groups at most severity levels. Not all secondary outcome details were broken down further in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03124108 · results posted 24 September 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT03124108) enrolled 45 people in total — 15 in each of three groups: one group received a daily 80 mg dose of elafibranor, one received a 120 mg dose, and one received a placebo (a dummy treatment with no active ingredient). Nearly all participants finished the study; only one person in the 120 mg group did not complete it. The trial ran for 12 weeks and was primarily measuring changes in a blood marker called alkaline phosphatase (ALP) — a substance that can be elevated in certain liver conditions — to see how much it changed from the start to the end of the study. The reported data shows that, on average, ALP levels fell by about 48% in the 80 mg group and about 41% in the 120 mg group over the 12 weeks, while in the placebo group ALP levels rose by roughly 3%. For the secondary measures, researchers used several scoring systems that combine ALP levels with other blood markers to define a "response." The reported data shows that under one combined measure, approximately 67% of the 80 mg group and 79% of the 120 mg group met the response criteria, compared with about 7% in the placebo group. Under another combined measure, around 73% of the 80 mg group and 43% of the 120 mg group met the criteria, while 0% of the placebo group did. Other scoring systems (Paris I, Paris II, and Toronto I) showed similar patterns of differences between the groups, with the placebo group generally recording lower response rates than either elafibranor group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02424175 · results posted 21 August 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 10 people, all of whom had a condition called primary sclerosing cholangitis (PSC), a disease affecting the bile ducts in the liver. All 10 participants completed the study. The trial was measuring three things: how often unwanted health events (called adverse events) occurred, whether a specific liver enzyme in the blood called alkaline phosphatase dropped by at least half after treatment, and whether the gut microbiome (the community of bacteria living in the digestive system) changed to become more similar to that of the donor. The reported data shows that out of the 10 participants, 8 experienced at least one adverse event of any level of seriousness. Regarding the alkaline phosphatase measure, the reported data shows that 3 out of 10 participants achieved a drop of 50% or more in their levels. For the microbiome outcome, the reported data shows that 8 out of 10 participants showed changes in their gut bacteria that made it more similar to the donor's microbiome after the procedure. It is worth noting that this was a very small study with only 10 participants, so the numbers reflect a limited group of people. No comparison group (such as a placebo group) was included in the reported data, meaning the figures above describe only what was observed in this single group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02943460 · results posted 12 March 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02943460) looked at a medicine called cilofexor, tested at two different doses (100 mg and 30 mg), compared against a placebo (a dummy treatment with no active ingredient). A total of 52 people took part in the blinded phase — meaning participants did not know which treatment they were receiving — with 22 in the 100 mg group, 20 in the 30 mg group, and 10 in the placebo group. The trial's main focus was on monitoring and recording unwanted medical events (called adverse events) and unusual blood test results that occurred during the treatment period. The reported data shows that, during the blinded phase, 81.8% of participants in the cilofexor 100 mg group, 70.0% in the cilofexor 30 mg group, and 100% in the placebo group experienced at least one treatment-emergent adverse event (an unexpected medical event that appeared after starting the study drug). Serious adverse events — defined as events involving hospitalisation, life-threatening situations, death, or other significant medical concerns — were reported in 13.6% of the cilofexor 100 mg group, and 0% in both the cilofexor 30 mg and placebo groups. The reported data also shows that abnormal blood or laboratory test results were recorded for 90.9% of the 100 mg group, 85.0% of the 30 mg group, and 100% of the placebo group. Further breakdowns of laboratory abnormalities by severity level were also reported, though a full description of each category was not provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02653625 · results posted 1 October 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 24 adults who were given cenicriviroc 150 mg, a drug being studied for a liver condition called Primary Sclerosing Cholangitis (PSC). Twenty participants finished the full 24 weeks of the study, while four did not complete it. The trial was mainly looking at changes in a blood marker called alkaline phosphatase (ALP) — a substance measured in the blood that can reflect how active PSC is in the liver. The reported data shows that, on average, participants' ALP levels fell by 4.5% from the start of the study to week 24 (a negative number here means a reduction in the marker). However, when looking at more specific targets, the results showed that 0% of participants had their ALP return to a normal range by week 24, and 0% achieved a 50% or greater drop in ALP. The reported data also shows that 10% of participants reached a level of ALP below 1.5 times the upper limit of what is considered normal. The trial also tracked unintended medical events that occurred after treatment began (called treatment-emergent adverse events). The reported data shows that 83.3% of participants experienced at least one such event during the study, and 8.3% stopped taking the treatment because of one. The trial data does not provide a breakdown of what those events were in this summary. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01802073 · results posted 21 September 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT01802073) looked at oral vancomycin — an antibiotic taken by mouth — in people with a liver condition called primary sclerosing cholangitis (PSC). A total of 34 people were enrolled: 14 children and 20 adults. Of those, 9 children and 9 adults completed the trial, while 5 children and 11 adults did not finish. The trial was measuring whether certain liver-related markers in the blood, and images or tissue samples of the liver, showed what the investigators judged to be a clinically significant improvement (meaning a meaningful change based on each person's history and disease stage) after 3 months and 1 year of treatment. The reported data shows the following for the blood marker results at 3 months. For a liver enzyme called ALT (a substance that can rise when the liver is under stress), 10 of the children and 6 of the adults who had elevated levels at the start were recorded as showing a clinically significant improvement. For another liver enzyme called GGT, 8 children and 6 adults with elevated levels at the start were recorded as showing a clinically significant improvement. When ALT and/or GGT were considered together, 10 children and 8 adults were recorded as showing a clinically significant improvement. The reported data also shows results at 1 year for imaging and tissue tests. For a special scan of the bile ducts called an MRCP, 6 children and 4 adults who had abnormal scans at the start were recorded as showing a clinically significant improvement. For liver biopsies (small tissue samples from the liver), 3 children and 0 adults with abnormal results at the start were recorded as showing a clinically significant improvement. When MRCP and/or biopsy results were considered together, 10 children and 4 adults were recorded as showing a clinically significant improvement. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02061540 · results posted 12 April 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 27 participants, all of whom received the study drug maralixibat (also known as LUM001). The trial was looking at a condition called cholestasis — a liver problem where bile does not flow properly — and measured several things over roughly 14 weeks: how many participants experienced unwanted health events (called adverse events) while taking the drug, changes in bile acid levels in the blood, changes in liver enzyme levels, changes in bilirubin levels (a substance linked to liver function), and changes in itching severity. Participants were given different doses of the drug. Twenty-three of the 27 participants completed the study, and four did not finish. The reported data shows that when it came to unwanted health events during the study, the numbers varied by dose group: 1 participant at the 1 mg dose, 2 at the 2.5 mg dose, 2 at the 5 mg dose, 1 at the 7.5 mg dose, and 19 at the 10 mg dose experienced such events. For bile acids in the blood, the reported starting (baseline) level was about 38.9 micromoles per litre, and by week 14 the reported change was a decrease of about 14.8 micromoles per litre. For liver enzymes, the reported data shows starting levels and changes across three enzymes (ALT, AST, and ALP), with baseline figures of approximately 108.5, 88.3, and 471.6 units per litre respectively, and reported changes of 10.5, 11.7, and 36.7 units per litre respectively — though the direction of those changes (up or down) was not clearly labelled in the submitted data. For bilirubin, starting levels were reported as approximately 1.22 mg/dL (total) and 0.60 mg/dL (direct), with reported changes of 0.24 and 0.19 mg/dL respectively. For itching, participants started with a weekly score of around 15 out of a possible 70 (scored on a daily 0–10 scale), and the reported change by the end of the study was a decrease of approximately 7.67 points. The reported data also shows changes in cholesterol markers: total cholesterol started at around 213 mg/dL with a reported change of −21.2 mg/dL, and LDL cholesterol started at around 121.4 mg/dL with a reported change of −16.3 mg/dL. It is important to note that these are the numbers as submitted to the registry, and the data as provided does not always specify which direction certain changes went or include full context for each figure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01473524 · results posted 13 February 2017

  According to the results reported on ClinicalTrials.gov, this trial involved people with a liver condition and was split into two phases. In the first phase (the "double-blind" phase), 217 participants were divided into three groups: one group received a dose of obeticholic acid (OCA) that could be adjusted between 5 mg and 10 mg, one group received a fixed 10 mg dose of OCA, and one group received a placebo (a dummy treatment with no active ingredient). Neither the participants nor the researchers knew who was receiving which treatment during this phase. After this 12-month phase, participants who wished to continue moved into a longer follow-up phase (called the LTSE phase), where 193 people received OCA for up to a further four years. The trial was measuring changes in two specific blood markers — alkaline phosphatase (ALP) and bilirubin — which are substances the liver produces that can be measured with a blood test. The reported data shows that at the end of the 12-month double-blind phase, 47% of participants in the fixed 10 mg OCA group met a specific combined blood-marker target (ALP below a certain level, bilirubin within normal range, and at least a 15% drop in ALP from the start), compared with 10% of participants in the placebo group. For the adjustable 5–10 mg OCA group, 46% met that same combined target at 12 months, versus 10% in the placebo group. In terms of the actual change in ALP levels, the reported data shows the adjustable-dose group had an average decrease of about 113 units per litre (U/L) and the fixed 10 mg group had an average decrease of about 130 U/L, while the placebo group had an average decrease of about 14 U/L. During the longer follow-up phase, the reported data shows that the proportion of participants meeting the combined blood-marker target generally increased over time across all groups — including among those who had originally been on placebo and switched to OCA — reaching around 54–61% at the later time points, though the data for some sub-groups at earlier time points was more variable. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01865812 · results posted 19 October 2016

  According to the results reported on ClinicalTrials.gov, this trial involved 27 participants in a primary treatment phase, of whom 25 completed that phase. A further 21 participants then entered a longer follow-up stage (called the Long-term Safety Extension Phase), with 15 of those completing it. The trial was measuring changes in HDL cholesterol — often called "good cholesterol" — looking specifically at its concentration (amount in the blood), the size of HDL particles, and the number of HDL particles, all before and after treatment. The reported data shows that by the end of the primary treatment phase, the average change in HDL cholesterol concentration from the starting point was −0.38 mmol/L (millimoles per litre, a standard unit for measuring substances in blood), meaning it was lower than at the start. The average change in HDL particle size was −0.44 nm (nanometres), and the average change in HDL particle number was −0.06 µmol/L. For the secondary measurements taken at weeks 4, 8, and 12, the reported data shows the HDL cholesterol concentration changed by approximately −0.21, −0.31, and +0.05 mmol/L respectively at those three time points. HDL particle size changed by −0.30, −0.30, and 0.00 nm, while HDL particle number changed by +0.55, +0.60, and +1.60 µmol/L at those same time points. It is worth noting that the reported data does not include a comparison group (for example, a placebo group), so these numbers reflect changes within the one group of participants only. No comparative figures were reported for the Long-term Safety Extension Phase outcomes in the data submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01904058 · results posted 6 July 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 66 adults in total across four groups. Participants were already taking a standard medication called UDCA (ursodeoxycholic acid) and were then given either a low dose (10 mg) or higher dose (20 mg) of an investigational drug called LUM001, or a placebo (a dummy treatment with no active ingredient), for 13 weeks. The trial was primarily measuring changes in itching — a common and troublesome symptom in liver conditions — using a diary-based scoring tool called the ItchRO, where participants rated their itch twice daily on a scale of 0 (no itch) to 10 (very severe itch). Of the 66 who started, 61 completed the trial. The reported data shows that at the start of the trial, all four groups had similar weekly itch sum scores (ranging roughly from 48 to 55 points out of a possible 70). By week 13, the reported changes in that weekly sum score were: a reduction of about 24.6 points in the LUM001 10 mg group, a reduction of about 27.7 points in the LUM001 20 mg group, a reduction of about 26.2 points in the placebo group for Cohort A, and a reduction of about 22.8 points in the placebo group for Cohort B. The reported data also shows changes were tracked at weeks 4 and 8 across secondary measures, including a separate five-dimension itch scale, average daily itch scores, and blood test results for alkaline phosphatase (a liver-related enzyme) and bile acid levels (substances that can build up in liver conditions). All four groups showed reductions in itch scores across most time points and measures, with figures for blood markers varying across the groups and time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01322386 · results posted 4 March 2016

  According to the results reported on ClinicalTrials.gov, this trial looked at the use of oral vancomycin (an antibiotic taken by mouth) in two groups of patients with liver conditions: those with biliary atresia (a condition where the bile ducts are blocked or missing) and those with primary sclerosing cholangitis, or PSC (a condition where the bile ducts become inflamed and scarred). Ten people were enrolled in the biliary atresia group and eleven in the PSC group. All ten participants in the biliary atresia group completed the study, while nine of the eleven PSC participants completed it, with two not finishing. The reported data shows that the trial measured possible changes using liver blood tests, MRI scans (a type of imaging), liver biopsies (small tissue samples from the liver), and colon biopsies (small tissue samples from the large bowel). For the biliary atresia group, the reported data shows that 10 out of 10 participants had liver blood test results recorded, but no MRI scans, liver biopsies, colon biopsies, or combined biopsy/MRI results were reported for this group. For the PSC group, the reported data shows 9 out of 9 participants had liver blood tests recorded, 7 had MRI scans, 4 had liver biopsies, 8 had colon biopsies, and 8 had either a liver biopsy and/or MRI. The data as submitted does not include the actual before-and-after numbers or results from these tests, only the counts of how many participants had each measurement taken. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01879735 · results posted 23 February 2015

  According to the results reported on ClinicalTrials.gov, this trial involved 22 people in total — 6 in a group receiving an ICG (indocyanine green) infusion, and 16 in a group receiving a substance called 11C-CSar delivered by a bolus (a single quick dose) followed by a constant drip. The trial was measuring whether researchers could use these methods to track and measure how the liver processes and transports certain substances, using specialised imaging techniques. The reported data shows one primary outcome was measured: the percentage of participants in each group for whom the researchers were able to successfully measure liver transport activity. According to the results reported on ClinicalTrials.gov, this figure was 100% in both groups — meaning that for every participant, the researchers reported being able to obtain a measurable result using the method being tested. No secondary outcome data appears to have been reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01389973 · results posted 15 October 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT01389973) enrolled 20 participants, all of whom received a medicine called ustekinumab (90 mg) in an open-label study — meaning everyone knew which treatment they were receiving. The trial was looking at whether the drug could reduce blood levels of a liver enzyme called alkaline phosphatase (ALP), which can be a marker of a liver condition. Notably, the reported data shows that none of the 20 participants were recorded as having completed the study. The reported data shows that the main thing the trial was measuring — whether a participant's ALP level dropped by more than 40% from their starting level by week 12 — was seen in zero out of 20 participants. The same result was reported at week 28: zero participants met the threshold for an ALP "response" (a large drop in the enzyme), and zero participants achieved ALP "remission" (a return to a lower, less concerning level). However, the reported data does show a small average percentage change in ALP levels at week 28 of around -11%, meaning levels were slightly lower on average than at the start, though this did not reach the target reduction. Three other liver-related measures — ALT, AST, and bilirubin — also showed small average reductions of around -9%, -7%, and -5% respectively at week 28, though again these figures simply reflect what was measured and recorded. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01249092 · results posted 9 December 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people, all of whom received a daily dose of a medication called pentoxifylline (400 mg per day). The trial was looking at people with a liver condition called primary biliary cirrhosis (PBC). Of the 20 who started, 18 completed the study, and 2 did not finish. The main thing being measured was a change in a blood marker called alkaline phosphatase — a substance measured in blood that can be linked to liver activity — after six months of treatment. The study also tracked a second blood marker called TIMP-1, which is associated with scarring (fibrosis) in the liver, as well as whether any serious unwanted health events occurred during the trial. The reported data shows that, on average, alkaline phosphatase levels changed by minus 57.3 U/L (units per litre) from the start of the study to the six-month mark, meaning the measured levels were lower at the end than at the beginning. For the secondary marker TIMP-1, the reported data shows an average change of minus 5.69 ng/mL (nanograms per millilitre), again indicating the measured levels were lower at the end of the study period. The reported data also shows that zero participants experienced a severe adverse (unwanted) health event during the study. No other figures beyond these averages were reported in the structured results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01085760 · results posted 19 September 2013

  According to the results reported on ClinicalTrials.gov, this trial looked at two antibiotics — vancomycin and metronidazole — each tested at a low and a high dose, in people with a liver condition called primary sclerosing cholangitis (PSC). A total of 35 people were enrolled across the four groups (8 on low-dose vancomycin, 9 on high-dose vancomycin, 9 on low-dose metronidazole, and 9 on high-dose metronidazole), and 28 completed the full 12 weeks. The trial measured changes in several blood markers over that period, with the main focus being a liver enzyme called alkaline phosphatase (ALP) — a substance found in the blood that doctors sometimes monitor in liver conditions. The reported data shows that after 12 weeks, ALP levels changed by different amounts in each group. In the low-dose vancomycin group, ALP dropped by an average of 117 units per litre (U/L); in the high-dose vancomycin group, it dropped by 49 U/L; in the low-dose metronidazole group, it dropped by 62 U/L; and in the high-dose metronidazole group, it dropped by 36 U/L. The reported data also shows changes in three secondary measures. For total bilirubin (another liver marker), levels fell slightly in the low-dose groups (−0.4 and −0.3 mg/dL for vancomycin and metronidazole respectively) but showed a small rise in both high-dose groups (+0.05 mg/dL each). A disease severity score called the Mayo PSC Risk Score — where higher numbers indicate worse disease — fell in all four groups, with the largest reported drop in the low-dose vancomycin group (−0.65). Finally, a general inflammation marker called C-reactive protein fell in the two low-dose groups (−2.2 and −3.6 mg/L) and showed little to no change in the high-dose groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01142323 · results posted 23 April 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 8 participants, all of whom completed the study — none dropped out. The trial was looking at the effects of a medicine called fenofibrate in people with a liver condition called Primary Sclerosing Cholangitis (PSC). The main thing being measured was a substance in the blood called alkaline phosphatase (a marker that doctors use to monitor liver-related changes), checked at the start of the study and again after 6 months. A secondary measure was something called the Mayo Risk Score, a calculated number based on several factors (including age, certain blood results, and history of bleeding) that is used to estimate risk. The reported data shows that the average alkaline phosphatase level in blood was 290 U/L (units per litre) at the start of the study, and 165 U/L at the 6-month mark. These are the numbers as submitted — the trial did not report a statistical comparison between these two figures, so no further detail on that is available. For the Mayo Risk Score, the reported data shows two score values of -0.41 and -0.46 for the fenofibrate group, though the data as submitted does not clearly separate these into "start" and "end" timepoints — as such, a direct before-and-after comparison cannot be described with certainty from the information provided. A score below zero, as noted in the study description, is described as indicating low risk. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00953615 · results posted 27 February 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled only one participant, who was assigned to receive thalidomide. The study was investigating whether thalidomide could affect certain liver-related measurements in people with primary sclerosing cholangitis (PSC), a condition involving scarring of the bile ducts in the liver. The plan was to track changes in liver enzyme levels (chemical markers measured in the blood), a survival estimate score called the Mayo Risk Score, and levels of a substance in the blood linked to inflammation, over a six-month period. The reported data shows that the single participant who started the trial did not complete it. Because of this, no outcome measurements were recorded or reported for any of the primary or secondary measures — including the liver enzyme levels, the Mayo Risk Score, the inflammation marker, or the tolerability and side-effect data. In other words, the trial was unable to generate any results from its measurements, as the data was not reported for any of the planned outcomes. The reported data therefore provides no numerical findings about how thalidomide affected any of the measures the trial set out to examine. This trial, as submitted to ClinicalTrials.gov, was not able to draw any conclusions due to the very small number of participants and the fact that no one completed the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00550862 · results posted 23 January 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 165 participants across four groups during the main double-blind phase (lasting about 12 weeks): 38 people received obeticholic acid (OCA) at 10 mg, 48 received OCA at 25 mg, 41 received OCA at 50 mg, and 38 received a placebo (a dummy treatment with no active ingredient). After the main phase, 78 participants moved into a longer follow-up phase lasting up to 12 months, where everyone received OCA. The trial was measuring changes in certain blood markers — particularly a liver-related enzyme called alkaline phosphatase (ALP) — to see how the levels shifted over time in each group. The reported data shows that the main goal of the trial was to measure the percentage change in ALP levels from the start to the end of the 12-week double-blind phase. According to the results reported on ClinicalTrials.gov, ALP levels fell by around 23.7% in the 10 mg OCA group, 24.7% in the 25 mg group, and 21.0% in the 50 mg group, compared to a drop of about 2.6% in the placebo group. The reported data also shows changes in other liver-related blood markers (AST, ALT, and GGT) and a protein called albumin. Across the OCA groups, those markers also showed reported percentage reductions ranging roughly from 13% to 29% over the 12 weeks, while the placebo group showed much smaller reported changes (generally under 5%). During the longer follow-up phase, the reported data shows continued reductions in ALP of around 22–24% from the start of that phase, with more modest reported changes in the other markers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00575042 · results posted 9 January 2012

  According to the results reported on ClinicalTrials.gov, this trial involved 20 people who were given fenofibrate (160 mg per day). It was a single-group study, meaning all participants received the same treatment — there was no comparison group receiving a different treatment or a dummy pill. The trial was measuring levels of a substance in the blood called alkaline phosphatase (ALP), which is an enzyme that can be elevated in certain liver and bone conditions. Of the 20 people who started the trial, 17 completed it and 3 did not finish. The reported data shows that the main thing being measured was the middle (or "median") ALP level in the blood — before and after one year of taking fenofibrate. Before treatment, the reported median ALP level was 351 U/L (units per litre, a standard way of measuring this enzyme in blood). After one year of treatment, the reported median ALP level was 175 U/L. No other outcome measures appear to have been submitted to ClinicalTrials.gov for this trial, so no further figures are available to report. It is important to note that these are numbers from a small group of 20 people, and the data as submitted does not include a separate untreated comparison group. No secondary outcome data was reported in the structured results available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00570765 · results posted 7 July 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people across three groups in its main double-blind phase: 20 received a 10 mg dose of obeticholic acid (OCA), 16 received a 50 mg dose, and 24 received a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring changes in a liver enzyme called alkaline phosphatase (ALP) — a substance found in the blood that doctors sometimes use as a marker of liver activity — after about 12 weeks (Day 85). A separate longer-term follow-up phase then tracked 28 participants over several years. The reported data shows that, by Day 85, the group taking 10 mg OCA had an average ALP level that was 44.5% lower than at the start, and the 50 mg group showed a 37.6% reduction, while the placebo group's ALP level was essentially unchanged (up by 0.4%). For two other liver markers — GGT and ALT — the reported data shows reductions of around 73% and 37% respectively in the 10 mg group, 65% and 35% in the 50 mg group, and much smaller changes (around −3% and −4%) in the placebo group. For a further marker called conjugated bilirubin, the reported numbers were small changes in the OCA groups (0.7% and −1.7%), compared with a 30.3% rise in the placebo group. Blood concentration levels of OCA were listed as a secondary measure but no numerical results were reported in the data. For the longer-term follow-up phase, the reported data shows median ALP reductions ranging from approximately 31.8% to 44.4% at various time points up to 72 months, though data on drug concentration levels was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.