Phase 2 Primary Biliary Cholangitis Trial, Recruiting NCT06905054 Sponsor: Mayo Clinic Condition: Primary Biliary Cholangitis
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Phase 2 Primary Biliary Cholangitis Trial, Recruiting

NCT06905054
Recruiting Phase 2

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 are an adult between 18 and 75 years old (any gender)
  • You received a liver transplant for a condition called PSC (primary sclerosing cholangitis) or a liver cancer related to PSC, between 1 and 7 years before joining the study
  • You do not currently show signs of PSC returning in your transplanted liver
  • You have at least one of the following features that may increase the chance of PSC returning: your transplant was done because of a bile duct cancer (cholangiocarcinoma); you have inflammatory bowel disease (such as Crohn's disease or ulcerative colitis); you had a CMV (cytomegalovirus) infection in your blood at any point after your transplant; or you had an episode of your immune system attacking your transplanted liver (acute rejection) after your transplant
  • You live within a 3-hour drive of Mayo Clinic Arizona, or you are willing and able to travel there every 4 months during the study at your own expense

Who may not be able to join:

  • You have a condition called ischemic cholangiopathy (bile duct damage due to reduced blood flow), which can look similar to PSC returning
  • Your liver transplant was done for a different liver condition — such as primary biliary cholangitis, autoimmune hepatitis, or a combination of PSC with either of those conditions
  • You have an unresolved problem with the blood supply to your transplanted liver (such as a blocked or narrowed hepatic artery)
  • You have had your entire large bowel (colon) removed as treatment for ulcerative colitis
  • Your kidneys are not working well enough (confirm with trial site) to safely take the study medication, fenofibrate
  • You have had a known allergic reaction or bad reaction to fenofibrate in the past
  • You have another serious health condition — including certain mental health conditions — that the study team feels could interfere with your participation or safety
  • You are pregnant or planning to become pregnant during 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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
15 April 2025
Est. completion
30 March 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

To determine the incidence of rPSC in LT recipients treated with fenofibrate, compared with an untreated control cohort.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov