RecruitingPhase 2NCT06905054

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


Sponsor

Mayo Clinic

Enrollment

80 participants

Start Date

Apr 15, 2025

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether fenofibrate — a commonly used, generic cholesterol medication — can prevent primary sclerosing cholangitis (PSC) from returning after a liver transplant. PSC is a chronic bile duct disease with no established medical treatment, and recurrence after transplant occurs in up to 27% of patients and often leads to graft failure. Adults aged 18 to 75 who received a liver transplant for PSC between 1 and 7 years ago, show no signs of recurrence yet, and have at least one risk factor for recurrence (such as concurrent inflammatory bowel disease or prior acute rejection) may be eligible. Participation involves taking once-daily fenofibrate for 36 months, with regular blood tests, advanced liver imaging, and follow-up visits at Mayo Clinic Arizona every 4 months. This summary was generated with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFenofibrate (drug)

Once daily fenofibrate for 36 months

DIAGNOSTIC_TESTBlood draw for the laboratory assessment

Serum assessments will be performed every 3 months during the study period

DIAGNOSTIC_TESTMRI using a hepatobiliary phase contrast agent (Gd-EOB-DPTA)

Participants will undergo a quantitative gadoxetate-enhanced MRI and MRCP at baseline, and at 12 months and 36 months of trial participation.


Locations(1)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

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NCT06905054


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