Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Tran… (NCT06905054) | Clinical Trial Compass
RecruitingPhase 2
Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation
United States80 participantsStarted 2025-04-15
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* 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.
Exclusion criteria:
* 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 w…
What they're measuring
1
To determine the incidence of rPSC in LT recipients treated with fenofibrate, compared with an untreated control cohort.