Peroxisome Proliferator-Activated Receptor Agonists to Prevent Primary Sclerosing Cholangitis Recurrence After Liver Transplantation
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
• 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
• If target enrollment of 40 patients is not achieved during the first 6 months of study, we will remove f(iii) inclusion criteria to expand enrollment to any patient meeting the other inclusion/exclusion criteria.
• 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.