AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation

RecruitingPhase 2Ages 18 Years - 75 YearsAllMayo Clinic
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
๐Ÿ’Š

What it tests

  • Fenofibrate (drug)
  • Blood draw for the laboratory assessment
  • MRI using a hepatobiliary phase contrast agent (Gd-EOB-DPTA)
๐Ÿ“

Where

1 site
Mayo Clinic in Arizona
Scottsdale, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy