Actively Recruiting
Peroxisome Proliferator-Activated Receptor Agonists to Prevent Primary Sclerosing Cholangitis Recurrence After Liver Transplantation
Led by Mayo Clinic · Updated on 2025-06-27
80
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Primary sclerosing cholangitis (PSC) is a progressive liver disease that often leads to liver transplantation (LT). This research evaluates whether taking fenofibrate once daily for 36 months can prevent the recurrence of PSC after liver transplantation compared to a group who did not receive this treatment. The study also explores new blood markers and advanced MRI techniques to detect early signs of disease progression before major liver damage occurs. Participants who had a liver transplant for PSC between 1 and 7 years ago will take 160 mg of fenofibrate daily for three years. Blood tests to measure bile acids and related markers will be done every three months. In addition, participants will have specialized MRI scans at the start, after 12 months, and at the end of the study to assess liver and bile duct function. The comparison group consists of historical patients who did not receive fenofibrate. Throughout the 36 months, participants will be closely monitored through regular blood tests and MRI imaging to track changes related to PSC recurrence. Researchers will measure how many develop recurrent PSC and analyze associations between blood markers, imaging results, and disease progression. This thorough follow-up aims to understand fenofibrate's role in preventing PSC recurrence and improving long-term outcomes after liver transplant.
CONDITIONS
Brief Title
Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years of any gender
- Underwent liver transplantation for primary sclerosing cholangitis or related liver cancer between 1 and 7 years before study enrollment
- No current recurrence of primary sclerosing cholangitis
- Have at least one of the following: transplant for cholangiocarcinoma, concurrent inflammatory bowel disease, past cytomegalovirus viremia after transplant, or past acute cellular rejection after transplant
- Willing and able to travel to Mayo Clinic Arizona every 4 months if living within 3 hours' drive
You will not qualify if you...
- Presence of ischemic cholangiopathy
- Liver transplant for primary biliary cholangitis, autoimmune hepatitis, or overlapping conditions
- Unaddressed hepatic artery problems after transplant
- History of total colectomy for ulcerative colitis
- Kidney function below a specific threshold (GFR <30 ml/min)
- Known intolerance or allergy to fenofibrate
- Other serious health or psychiatric conditions affecting treatment or compliance
- Pregnant or planning pregnancy
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 36 months
Participants receive once daily fenofibrate for 36 months to prevent recurrence of primary sclerosing cholangitis after liver transplantation. Serum assessments will be performed every 3 months to monitor bile acids and related biomarkers. Participants will also undergo quantitative gadoxetate-enhanced MRI and MRCP at baseline, 12 months, and 36 months to assess biliary flow dynamics and liver condition.
Quarterly visits every 3 months for blood draws and 3 MRI visits at baseline, 12 months, and 36 months
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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