Fenofibrate for Primary Sclerosing Cholangitis

Recruiting in Palo Alto (17 mi)

Overseen byChanna Jayasekera

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of 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

Research Team

Channa Jayasekera

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for individuals who have had a liver transplant due to primary sclerosing cholangitis (PSC) and are at risk of recurrence. Specific eligibility criteria were not provided, but typically participants would need to meet certain health standards and may be required to have no history of allergic reactions to the interventions being tested.

Inclusion Criteria

I had a liver transplant for cancer, have bowel disease, or had certain infections or rejections after my transplant.

I had a liver transplant for PSC or related cancer between 1 and 7 years ago.

I can travel to Mayo Clinic Arizona every 4 months at my own expense.

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Exclusion Criteria

I am pregnant or planning to become pregnant.

I have a condition that looks like rPSC affecting my bile ducts.

I had a liver transplant due to specific liver conditions and have unresolved issues with the liver's blood supply.

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Treatment Details

Interventions

Fenofibrate (Other)

Trial OverviewThe study tests if taking fenofibrate daily for 36 months can prevent PSC from coming back after a liver transplant. It's compared with past data where patients didn't get this treatment. Participants will also undergo MRI scans using Gd-EOB-DPTA contrast agent and regular blood tests.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: TreatmentExperimental Treatment3 Interventions

Individuals who underwent liver transplantation for primary sclerosing cholangitis 1-7 years before study initiation, and meeting study criteria, will receive fenofibrate 160mg oral daily for 36 months Participants will undergo the following serum assessments as part of the study every 3 months during the study period: total bile acids, bile acid profile, fibroblast growth factor 19, and 7-alpha-C4 Participants will undergo gadoxate-enhanced magnetic resonance imaging at baseline, 12 months, and 36 months.

Group II: Historical controlActive Control1 Intervention

Historical control of individuals who underwent liver transplantation for primary sclerosing cholangitis who were not treated with any peroxisome proliferator activated receptor agonist treatment.