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 (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.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 41173015) ↗
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 3 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 a specific type of bile duct condition called large duct PSC (primary sclerosing cholangitis)
- A liver biopsy taken during the screening process shows an acceptable sample with scarring rated at a low-to-moderate level (stage F0 to F3, meaning not the most severe level)
- Your platelet count (cells that help blood clot) is at or above 150,000/mm³
- Your kidneys are functioning at an acceptable level, based on a standard calculation from your blood test results
- Your liver enzyme levels (ALT) are not more than 8 times the upper limit of normal
- Your bilirubin level (a substance made by the liver) is below 2 mg/dL, unless you have a known condition called Gilbert's syndrome or a blood condition called hemolytic anemia
- A blood clotting measurement (INR) is at or below 1.4, unless you are taking blood-thinning medication for another reason
- A specific antibody test (anti-mitochondrial antibody) comes back negative
Who may not be able to join:
- You have or have previously had advanced liver scarring (cirrhosis)
- You have previously had a liver transplant
- You have or have previously had bile duct cancer (cholangiocarcinoma) or liver cancer (hepatocellular carcinoma)
- You had a serious bile duct infection (ascending cholangitis) within the 30 days before screening
- You currently have a drain through the skin or a tube (stent) placed in your bile ducts
- You have another condition that is causing liver disease
- You have or have previously had an unstable heart or blood vessel condition
- You currently have moderate to severe inflammatory bowel disease, such as ulcerative colitis, Crohn's disease, or indeterminate colitis
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: Gilead Study Director, Gilead Sciences
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
13 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants With Progression of Liver Fibrosis at Blinded Phase Week 96
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.