Actively Recruiting
Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation
Led by Mayo Clinic · Updated on 2025-06-27
80
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to determine the efficacy of 36 months once-daily fenofibrate in preventing clinically-detectable recurrence of primary sclerosing cholangitis after liver transplantation, compared with a historical control cohort that was not treated with
CONDITIONS
Official Title
Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18-75 irrespective of gender who have undergone liver transplantation for PSC or PSC-related liver malignancy between 1 and 7 years prior to enrollment
- No evidence of recurrent PSC at time of enrollment
- At least one of the following: liver transplant for cholangiocarcinoma, concurrent inflammatory bowel disease, any episode of cytomegalovirus viremia post-transplant, or any episode of acute cellular rejection post-transplant
- Willingness and ability to travel to Mayo Clinic Arizona every 4 months for study visits if living within 3 hours or willing to travel at own cost
You will not qualify if you...
- Presence of ischemic cholangiopathy that can mimic recurrent PSC
- Liver transplant performed for primary biliary cholangitis, autoimmune hepatitis, or overlapping conditions that may recur and affect assessment
- Untreated hepatic artery complications after transplant (e.g., thrombosis, stenosis)
- History of total colectomy for ulcerative colitis
- Baseline kidney function (GFR) below 30 ml/min
- Known intolerance or allergy to fenofibrate
- Significant other health conditions or psychiatric disorders interfering with treatment or compliance
- Pregnant women or those planning pregnancy
AI-Screening
AI-Powered Screening
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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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