Trial 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
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.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 39140490) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 4 Primary Biliary Cholangitis Trial, Terminated
Who may be able to join
AI generated eligibility 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
Who might be able to join this trial:
- You have been diagnosed with, or are likely to have, a liver condition called Primary Biliary Cholangitis (PBC), confirmed by at least 2 of the following: abnormal liver enzyme (alkaline phosphatase) levels for at least 6 months, a positive blood test for certain antibodies linked to PBC, or a liver biopsy that shows signs of PBC.
- Your blood tests show that certain liver markers (bilirubin and/or alkaline phosphatase) are above the normal range but not extremely high (confirm with trial site for exact levels).
- You are either not currently taking a medication called UDCA and have not taken it for the past 3 months, OR you have been taking UDCA at a stable dose for at least 12 months before joining the trial.
Who may not be able to join:
- You have another liver condition at the same time, such as Hepatitis C, active Hepatitis B, primary sclerosing cholangitis, alcoholic liver disease, autoimmune hepatitis, non-alcoholic steatohepatitis (fatty liver disease), or Gilbert's Syndrome (confirm with trial site if you have had Hepatitis B in the past).
- You have had a liver transplant, are currently on a liver transplant waiting list, or have a liver disease severity score above a certain level (confirm with trial site).
- You have serious complications from PBC, such as internal bleeding from swollen veins, uncontrolled fluid build-up in the abdomen, confusion caused by liver failure, or serious abdominal infections — within the past 12 months or currently.
- You have known or suspected liver cancer, or have had a specific surgical procedure to manage liver blood flow (called a TIPS procedure).
- You have a serious kidney problem or your kidney function test results are above a certain level (confirm with trial site).
- Your bilirubin blood level is more than 5 times the upper limit of normal.
- You have had gastric bypass surgery or had part of your small intestine removed, or are planning to have either of these procedures.
- You have another serious illness, such as an active cancer (other than very minor, stable forms), that may affect how long you are expected to live.
- You are pregnant, planning to become pregnant, or are breastfeeding (if female).
- You have a known HIV infection.
- You have a medical condition unrelated to your liver that could cause the same liver enzyme (ALP) to be raised, such as Paget's disease or a bone fracture in the past 3 months.
- You have other significant health conditions that are not well managed, or where your medications are likely to need changing during the study.
- You have had a problem with alcohol or other substance misuse within the past year.
- You have taken part in another clinical trial within the past 30 days (a previous trial of the study drug OCA may be allowed after a 3-month break — confirm with trial site).
- You have a mental health condition that may make it difficult to give informed consent or reliably follow the study requirements.
- You have had a known allergic reaction to the study drug (OCA) or any of its ingredients.
- You have never taken UDCA and there is no medical reason why you cannot take it.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Erik Ness, MD, Intercept Pharmaceuticals
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
9 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Time to the First Occurrence of Composite Endpoint; Time to the First Occurrence of Primary Clinical Event (Expanded Endpoint)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.