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 (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.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 30661255) ↗
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 2 Primary Biliary Cholangitis Trial, Completed
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 Primary Sclerosing Cholangitis (PSC), confirmed by a special imaging scan of your bile ducts within the past 12 months
- A specific liver enzyme in your blood called alkaline phosphatase (ALP) is above a certain elevated level
- If you take a medication called ursodeoxycholic acid (UDCA), your dose has been the same for at least 12 months before joining and must stay the same throughout the trial; if you do not take it, you must not have taken it for at least 12 months before joining
- If you take certain immune system medications (such as biologics, immunosuppressants, or steroid tablets), your dose has been stable for at least 3 months before joining and is expected to stay stable throughout the trial
- Your liver scarring score (measured by a blood test called FibroSURE/FibroTest®) is below a certain level, or a recent liver biopsy within the past 12 months shows no cirrhosis (confirm with trial site)
Who may not be able to join:
- A liver enzyme called ALT is more than 10 times the upper limit of normal in your blood test
- Your blood bilirubin level (a measure of liver function) is more than twice the upper limit of normal
- Your blood clotting measure (INR) is above 1.2, unless you are already on blood-thinning medication
- You have a specific form called "small-duct PSC," where bile ducts appear normal on imaging but PSC is seen on a biopsy
- You have another cause of liver disease, such as a viral, alcohol-related, inherited, or other autoimmune liver condition (those with fatty liver may still be eligible if there is no sign of a more serious form called NASH — confirm with trial site)
- You have had a bile duct infection (ascending cholangitis) within the past 60 days
- You currently have a drain or stent in your bile ducts
- You have taken certain medications called fibrates or obeticholic acid within the past 3 months
- You have advanced liver scarring (cirrhosis), shown by a biopsy, a history of serious liver complications (such as fluid buildup, confusion caused by liver disease, or bleeding from swollen veins), or a liver stiffness reading above 14.4 kPa on a FibroScan test
- You currently have active inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) with symptoms above a certain level of severity (confirm with trial site)
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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Percentage of Participants Experiencing Treatment-Emergent Adverse Events During the Blinded Phase; Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events During the Blinded Phase; Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities During the Blinded Phase
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.