Preventing recurrence of primary sclerosing cholangitis after liver transplantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of fenofibrate, administered once daily for 36 months, in preventing the recurrence of primary sclerosing cholangitis (PSC) in patients who have undergone liver transplantation. PSC is a progressive liver disease that can lead to serious complications, including graft loss. The study compares the outcomes of patients receiving fenofibrate to a historical control group that did not receive this treatment. Participants will be monitored for signs of biliary injury and cholestasis, which are indicators of disease progression.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic in Arizona
  Scottsdale, Arizona, United States Recruiting

Study contacts

• Principal investigator: Channa Jayasekera — Mayo Clinic

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Collecting bile samples from patients with Primary Sclerosing Cholangitis and controls

  This study is collecting bile samples from people with Primary Sclerosing Cholangitis and healthy individuals to see how the disease affects the body and find new ways to treat it.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT04753996

• Elafibranor for adults with primary sclerosing cholangitis

  This trial will see if taking elafibranor once daily helps adults with primary sclerosing cholangitis compared with a placebo.

  Recruiting at 41 sites Phase 3 Ipsen · Chandler, Arizona and 230 other locations · NCT07387549

• TAK-781 treatment in healthy adults and people with non-cirrhotic primary sclerosing cholangitis

  This study will test whether TAK-781 is safe and tolerable in healthy adults and in people with non-cirrhotic primary sclerosing cholangitis while measuring how the body handles and responds to the drug.

  Recruiting Phase 1 Takeda · Salt Lake City, Utah · NCT07229911

• CytoGam immunoglobulin to prevent late CMV disease after liver or kidney transplant

  This trial will try giving monthly CytoGam infusions after standard antiviral pills end to see if it lowers the chance of late CMV disease in high-risk liver, kidney, or combined liver-kidney transplant patients (donor positive, recipient negative).

  Recruiting at 2 sites Phase 4 Massachusetts General Hospital · Boston, Massachusetts and 1 other locations · NCT06958796

• Colangioids to find genetic causes of atypical primary sclerosing cholangitis

  This project will use lab-grown bile duct organoids (colangioids) to test which genetic changes are linked to atypical primary sclerosing cholangitis in adults with confirmed or suspected PSC or in available liver tissue.

  Recruiting Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Milan, MI · NCT06865924

• LEOPARD: Predicting liver transplant dropout with AI in European patients

  This project tests new AI-based models to predict which liver transplant candidates are at highest risk of dropout or death while on the waitlist.

  Recruiting at 4 sites Assistance Publique - Hôpitaux de Paris · Ghent, Belgium and 7 other locations · NCT06723275

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.