MedTrace Logo

Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation

NCT06905054 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-06-27

No results posted yet for this study

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

Interventions

DRUG

Fenofibrate (drug)

Once daily fenofibrate for 36 months

DIAGNOSTIC_TEST

Blood draw for the laboratory assessment

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

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

Principal Investigators

  • Channa Jayasekera · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-15
Primary Completion
2028-03-30
Completion
2028-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06905054 on ClinicalTrials.gov