Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06905054

Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation

Led by Mayo Clinic · Updated on 2025-06-27

80

Participants Needed

1

Research Sites

167 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18-75 irrespective of gender who have undergone liver transplantation for PSC or PSC-related liver malignancy between 1 and 7 years prior to enrollment
  • No evidence of recurrent PSC at time of enrollment
  • At least one of the following: liver transplant for cholangiocarcinoma, concurrent inflammatory bowel disease, any episode of cytomegalovirus viremia post-transplant, or any episode of acute cellular rejection post-transplant
  • Willingness and ability to travel to Mayo Clinic Arizona every 4 months for study visits if living within 3 hours or willing to travel at own cost
Not Eligible

You will not qualify if you...

  • Presence of ischemic cholangiopathy that can mimic recurrent PSC
  • Liver transplant performed for primary biliary cholangitis, autoimmune hepatitis, or overlapping conditions that may recur and affect assessment
  • Untreated hepatic artery complications after transplant (e.g., thrombosis, stenosis)
  • History of total colectomy for ulcerative colitis
  • Baseline kidney function (GFR) below 30 ml/min
  • Known intolerance or allergy to fenofibrate
  • Significant other health conditions or psychiatric disorders interfering with treatment or compliance
  • Pregnant women or those planning pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Arizona

Scottsdale, Arizona, United States, 85259

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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