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 (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.
View full results on ClinicalTrials.gov ↗
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, 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 primary sclerosing cholangitis (PSC), confirmed by at least two of the following: a past blood test showing a raised liver enzyme called alkaline phosphatase, a liver biopsy that matches PSC, or a scan/procedure showing abnormal bile ducts consistent with PSC.
- Your blood test results at the screening visit fall within specific ranges for several liver, kidney, and blood measures, including alkaline phosphatase, bilirubin, liver enzymes, kidney function, platelets, a clotting measure (INR), and protein levels (confirm with trial site for exact values).
- If you are taking a medication called ursodeoxycholic acid (UDCA), you may still be eligible as long as your daily dose is no more than 20 mg per kilogram of your body weight, you have been on a stable dose for at least 6 months, or — if you recently stopped taking it — you stopped at least 12 weeks before your screening visit.
Who may not be able to join:
- You have a significant liver disease caused by something other than PSC.
- You have been diagnosed with both PSC and a condition called autoimmune hepatitis (AIH) at the same time.
- Your bile duct condition is caused by something other than PSC, such as IgG4-related disease or a secondary cause.
- You have a type of PSC that affects only the very small bile ducts (called small duct PSC).
- A scan at your screening visit shows signs of a type of bile duct cancer called cholangiocarcinoma.
- You have had a bile duct stent, drain, or a procedure to widen a narrowed bile duct within the 12 weeks before your screening visit.
- You have a history of, or strong suspicion of, bile duct cancer or other liver/bile duct cancers.
- You have had a bile duct infection (acute cholangitis) within 12 weeks before your screening visit or before the first day of the trial.
- You have signs of advanced liver scarring (cirrhosis), based on a past liver biopsy, certain medical complications such as fluid build-up in the abdomen, confusion caused by liver problems, or bleeding from swollen veins, or specific abnormal blood/scan results indicating severe liver damage.
- You have previously had a liver transplant or are currently on a waiting list for one.
- You have previously taken the study drug, seladelpar.
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
Relative Change in Baseline Serum Alkaline Phosphatase (AP) at Week 24
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.