Preventing recurrence of primary sclerosing cholangitis after liver transplantation
Peroxisome Proliferator-Activated Receptor Agonists to Prevent Primary Sclerosing Cholangitis Recurrence After Liver Transplantation
This study is testing if a daily medication called fenofibrate can help prevent primary sclerosing cholangitis from coming back in people who have had a liver transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Scottsdale, Arizona) |
| Trial ID | NCT06905054 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 who have undergone liver transplantation for PSC or related malignancies and are free of recurrent PSC at enrollment.
Not a fit: Patients who have already experienced recurrent PSC or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of recurrent PSC and improve long-term outcomes for liver transplant patients.
How similar studies have performed: While previous trials for PSC treatments have been inconclusive, this approach using fenofibrate is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Scottsdale, Arizona
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Channa Jayasekera — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.