NCT06905054 Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation
| NCT ID | NCT06905054 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mayo Clinic |
| Condition | Primary Sclerosing Cholangitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-04-15 |
| Primary Completion | 2028-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2025-04-15 with a primary completion date of 2028-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility 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
Contact & Investigator
Channa Jayasekera
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06905054 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Primary Sclerosing Cholangitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06905054 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06905054 currently recruiting?
Yes, NCT06905054 is actively recruiting participants. Visit ClinicalTrials.gov or contact Mayo Clinic to inquire about joining.
Where is the NCT06905054 trial being conducted?
This trial is being conducted at Scottsdale, United States.
Who is sponsoring the NCT06905054 clinical trial?
NCT06905054 is sponsored by Mayo Clinic. The principal investigator is Channa Jayasekera at Mayo Clinic. The trial plans to enroll 80 participants.