RECRUITING

Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation

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Conditions

Primary Sclerosing CholangitisLiver Transplant, ComplicationsPSCBiliary Stricturesrecurrent primary sclerosing cholangitisliver transplant complicationfenofibratefibratePPAR agonistperoxisome proliferated activated receptor agonist

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Peroxisome Proliferator-Activated Receptor Agonists to Prevent Primary Sclerosing Cholangitis Recurrence After Liver Transplantation

Quick Facts

Study Start:2025-04-15
Study Completion:2028-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06905054

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Absence of rPSC at time of study enrollment
  3. * At least one of the following additional features that increase risk of rPSC
  4. * LT performed for cholangiocarcinoma
  5. * Concurrent inflammatory bowel disease
  6. * Any episode of cytomegalovirus viremia in the post-transplant period before study enrollment
  7. * Any episode of acute cellular rejection in the post-transplant period before the study enrollment
  8. * 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.
  9. * 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.
  1. * Presence of ischemic cholangiopathy which can mimic rPSC
  2. * 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
  3. * Unaddressed post-LT hepatic artery compromise (e.g thrombosis, stenosis) which can mimic rPSC
  4. * History of total colectomy for curative treatment of ulcerative colitis which reduces risk of rPSC
  5. * Baseline GFR \<30 ml/min which precludes administration of fenofibrate
  6. * Previously known intolerance or allergy to fenofibrate
  7. * 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
  8. * Female participants that are pregnant or planning to become pregnant

Contacts and Locations

Principal Investigator

Channa Jayasekera
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Channa Jayasekera, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-15
Study Completion Date2028-07-01

Study Record Updates

Study Start Date2025-04-15
Study Completion Date2028-07-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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