Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT06905054
Phase
PHASE2
Status
Recruiting
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Conditions

  • Biliary Strictures
  • Liver Transplant, Complications
  • PSC
  • Primary Sclerosing Cholangitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Fenofibrate (drug) — DRUG
    Once daily fenofibrate for 36 months
  • Blood draw for the laboratory assessment — DIAGNOSTIC_TEST
    Serum assessments will be performed every 3 months during the study period
  • MRI using a hepatobiliary phase contrast agent (Gd-EOB-DPTA) — DIAGNOSTIC_TEST
    Participants will undergo a quantitative gadoxetate-enhanced MRI and MRCP at baseline, and at 12 months and 36 months of trial participation.

Study Details

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

Key Dates

Start date
Apr 15, 2025
Status verified
Jun 2025
Primary completion
Mar 30, 2028
Completion
Jul 1, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259
Han Ly
[email protected]
480-574-2321
Channa Jayasekera (PRINCIPAL_INVESTIGATOR)

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