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 only one participant, who was assigned to receive thalidomide. The study was investigating whether thalidomide could affect certain liver-related measurements in people with primary sclerosing cholangitis (PSC), a condition involving scarring of the bile ducts in the liver. The plan was to track changes in liver enzyme levels (chemical markers measured in the blood), a survival estimate score called the Mayo Risk Score, and levels of a substance in the blood linked to inflammation, over a six-month period. The reported data shows that the single participant who started the trial did not complete it. Because of this, no outcome measurements were recorded or reported for any of the primary or secondary measures — including the liver enzyme levels, the Mayo Risk Score, the inflammation marker, or the tolerability and side-effect data. In other words, the trial was unable to generate any results from its measurements, as the data was not reported for any of the planned outcomes. The reported data therefore provides no numerical findings about how thalidomide affected any of the measures the trial set out to examine. This trial, as submitted to ClinicalTrials.gov, was not able to draw any conclusions due to the very small number of participants and the fact that no one completed the study. 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 previously diagnosed with a condition called primary sclerosing cholangitis (PSC), confirmed through specific blood tests, imaging of the bile ducts, and a liver tissue sample
- You are willing and able to sign a written consent form agreeing to take part in the study
- You are willing and able to follow a special safety program required by the FDA for the study medication (thalidomide), which includes strict guidelines around pregnancy prevention
Who may not be able to join:
- You are currently pregnant or breastfeeding
- You are unable or unwilling to use contraception to prevent pregnancy during the trial
- You have previously had an allergic reaction to thalidomide
- You are unable to give informed consent to participate
- You have a liver condition caused by something other than PSC, such as alcoholic liver disease, hepatitis B or C, or several other specific liver conditions
- Your doctors expect you may need a liver transplant within one year due to serious liver complications
- You have taken certain medications (including steroids, methotrexate, or several others) in the past three months (confirm with trial site for the full list)
- You have a history of nerve damage in your hands or feet (peripheral neuropathy)
- You currently take medications that are known to interact significantly with thalidomide (confirm with trial site)
- You have HIV or AIDS
- You have a serious or advanced cancer
- You have severe heart disease
- You have severe kidney disease
- You currently drink excessively or have done so in the past 6 months
- You have a history of blood clots or clotting events
- You have any other condition that the trial doctors feel would prevent you from safely completing the study
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
Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase
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.