Recruiting
Phase 2

Pharmacologic Approaches

Sponsor:

Mayo Clinic

Code:

NCT06905054

Conditions

Primary Sclerosing Cholangitis

Liver Transplant, Complications

PSC

Biliary Strictures

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Fenofibrate (drug)

Blood draw for the laboratory assessment

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

Study Details

Brief 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

Conditions

Primary Sclerosing Cholangitis

Liver Transplant, Complications

PSC

Biliary Strictures

Study ID

NCT06905054

Start date

Apr 15, 2025

Status verified date

Jul, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Mar 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

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.

no intervention: Historical control

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

Interventions

Fenofibrate (drug)

Once daily fenofibrate for 36 months

Blood draw for the laboratory assessment

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

MRI 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.

Primary outcome measure

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

Central Contacts and Locations

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Han Ly

480-574-2321ly.ngochan@mayo.edu

Principal Investigator:

Channa Jayasekera

More Information

Sponsor

Mayo Clinic

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Keywords

  • primary sclerosing cholangitis
  • recurrent primary sclerosing cholangitis
  • liver transplant complication
  • fenofibrate
  • fibrate
  • PPAR agonist
  • peroxisome proliferated activated receptor agonist

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-07-17.