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 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.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 38976363) ↗
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 1 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 liver condition called Primary Sclerosing Cholangitis (PSC), confirmed through a special imaging scan of your bile ducts or a liver biopsy
- You have evidence of liver scarring (cirrhosis), confirmed through a past liver biopsy, an abdominal scan (MRI, CT, or ultrasound), or a specific liver stiffness test done at screening
- Your kidneys are working well enough, based on a blood test result at your screening visit (confirm with trial site)
- Your liver enzyme levels (ALT) are not too high — no more than 5 times the upper limit of normal, based on a blood test
- Your blood clotting score (INR) is 1.4 or below, unless you are taking blood-thinning medication for another reason
- Your platelet count (cells that help blood clot) is at or above 75,000 per microliter, based on a blood test
- A specific blood test called anti-mitochondrial antibody comes back negative
Who may not be able to join:
- You have had, or currently have, serious liver complications such as fluid build-up in the abdomen (ascites), confusion caused by liver failure (hepatic encephalopathy), or bleeding from swollen veins in the food pipe or stomach
- You have previously had a liver transplant
- You have been diagnosed with bile duct cancer (cholangiocarcinoma) or liver cancer (hepatocellular carcinoma)
- Your liver disease severity score (called MELD score) is above 12 at screening, unless another medical reason explains the result
- Your liver function score (called Child-Pugh score) is above 6 at screening, unless another medical reason explains the result
- You currently have moderate to severe active inflammatory bowel disease (such as ulcerative colitis or Crohn's disease) — though people with an ostomy bag or who have had their colon removed may still be eligible (confirm with trial site)
- You have high-risk swollen veins in your food pipe or stomach, in the opinion of the medical team
- Your bilirubin (a substance measured in blood) is above 2 mg/dL, unless you have a condition called Gilbert's syndrome or a specific type of anemia (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
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Trial details
Where this trial is recruiting
Primary endpoints
Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs); Percentage of Participants Who Experienced Treatment Emergent Serious Adverse Events (SAEs); Percentage of Participants Who Experienced Laboratory Abnormalities
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.