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Fenofibrate for Preventing PSC Recurrence After Liver Transplant

This study is looking at whether a drug called fenofibrate can help prevent primary sclerosing cholangitis (PSC) from coming back after a liver transplant. PSC is a liver disease that often leads to a transplant, and it can sometimes return afterward. Participants will take fenofibrate once daily for 36 months. Researchers will compare how often PSC comes back in people taking fenofibrate versus a group who didn't receive this treatment. To join, you must be 18-75 years old, have had a liver transplant for PSC 1-7 years ago, and not currently have recurrent PSC. You also need to have other risk factors for PSC recurrence, such as having inflammatory bowel disease. The main goal is to see if fenofibrate reduces the chance of PSC recurrence after 36 months.

Study design
This interventional study plans to enroll 80 participants. It compares participants treated with fenofibrate to a historical control group.
What's involved
You would take fenofibrate once daily for 36 months. You would also have blood draws every 3 months and MRI scans at the beginning, 12 months, and 36 months of the study.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 36 months, indicating follow-up for at least that duration.

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NCT06905054

Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Mayo Clinic
~80 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:Fenofibrate (drug)Blood draw for the laboratory assessmentMRI using a hepatobiliary phase contrast agent (Gd-EOB-DPTA)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine the incidence of rPSC in LT recipients treated with fenofibrate, compared with an untreated control cohort.
Measured over 36 months

Conditions

Primary Sclerosing Cholangitis
Liver Transplant, Complications
PSC
Biliary Strictures

Explore related trials

Primary Sclerosing Cholangitis

Where it's being run

1 sites across 1 states
Arizona1

Study leadership

  • Channa Jayasekera · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Han Ly
[email protected]
480-574-2321
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

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 which reduces risk of rPSC
Baseline GFR \<30 ml/min which precludes administration of fenofibrate
Previously known intolerance or allergy to fenofibrate
Other clinically significant comorbid condition, including inability to provide consent and psychiatric conditions, which in the opinion of the study team, may interfere with patient treatment, safety, assessment, or compliance with the treatment
Female participants that are pregnant or planning to become pregnant

What this trial measures

  • To determine the incidence of rPSC in LT recipients treated with fenofibrate, compared with an untreated control cohort.36 months

    Proportion of recipients transplanted for PSC who develop rPSC during a 36-month fenofibrate treatment period, compared to the rate of rPSC in a untreated cohort. The diagnosis of rPSC will be made based on established diagnostic criteria (see Study Design)