Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation
Peroxisome Proliferator-Activated Receptor Agonists to Prevent Primary Sclerosing Cholangitis Recurrence After Liver Transplantation
Mayo Clinic
80 participants
Apr 15, 2025
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria8
- Adults aged 18-75 irrespective of gender who have undergone LT for PSC or PSC-related liver malignancy between 1 year and 7 years (inclusive) prior to study enrollment
- Absence of rPSC at time of study enrollment
- At least one of the following additional features that increase risk of rPSC
- LT performed for cholangiocarcinoma
- Concurrent inflammatory bowel disease
- Any episode of cytomegalovirus viremia in the post-transplant period before study enrollment
- Any episode of acute cellular rejection in the post-transplant period before the study enrollment
- Due to lab requirements, we will only enrol patients who are within a 3 hour driving distance of Mayo Clinic Arizona and/or are willing to travel to Mayo Clinic Arizona at 4 month intervals during the study at own cost.
Exclusion Criteria8
- Presence of ischemic cholangiopathy which can mimic rPSC
- LT performed for primary biliary cholangitis or autoimmune hepatitis, or PSC with overlapping primary biliary cholangitis or autoimmune hepatitis, which may recur after LT and confound assessment of cholestasis
- Unaddressed post-LT hepatic artery compromise (e.g thrombosis, stenosis) which can mimic rPSC
- History of total colectomy for curative treatment of ulcerative colitis which reduces risk of rPSC
- Baseline GFR <30 ml/min which precludes administration of fenofibrate
- Previously known intolerance or allergy to fenofibrate
- Other clinically significant comorbid condition, including inability to provide consent and psychiatric conditions, which in the opinion of the study team, may interfere with patient treatment, safety, assessment, or compliance with the treatment
- Female participants that are pregnant or planning to become pregnant
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Once daily fenofibrate for 36 months
Serum assessments will be performed every 3 months during the study period
Participants will undergo a quantitative gadoxetate-enhanced MRI and MRCP at baseline, and at 12 months and 36 months of trial participation.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06905054