Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMayo Clinic
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
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
Trial design
Treatments tested in this trial
- Fenofibrate (drug)
- Blood draw for the laboratory assessment
- MRI using a hepatobiliary phase contrast agent (Gd-EOB-DPTA)
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov