Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation
Phase 2 · Testing Fenofibrate (drug), Blood draw for the laboratory assessment and MRI using a… · 1 site · Mayo Clinic
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Fenofibrate (drug) (a drug), Blood draw for the laboratory assessment (a diagnostic test) and MRI using a hepatobiliary phase contrast agent (Gd-EOB-DPTA) (a diagnostic test) as a possible treatment. Condition(s) listed: Primary Sclerosing Cholangitis, Liver Transplant, Complications and PSC.
It is open-label: participants know what they are receiving.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 3 more requirement(s). There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 80 participants are expected to take part.
- The study has 2 groups.
- Start date: 2025-04-15.
- Main results expected around 2028-03-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Groups in this study
- Treatment (listed as: experimental group)
- Historical control (listed as: no-intervention group)
Main thing being measured
- To determine the incidence of rPSC in LT recipients treated with fenofibrate, compared with an untreated control cohort. (36 months)
In the researchers’ words
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
Words you might see
- Cholangiocarcinoma: cancer of the bile ducts.
- Cholestasis: reduced or blocked flow of bile.
- PBC: primary biliary cholangitis, a different chronic bile-duct disease.
- Autoimmune hepatitis: a liver disease where the immune system attacks the liver.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Primary Sclerosing Cholangitis; Liver Transplant, Complications; PSC; Biliary Strictures |
| Lead sponsor | Mayo Clinic |
| Enrollment | 80 (estimated) |
| Start date | 2025-04-15 |
| Primary completion (est.) | 2028-03-30 |
| First posted | 2025-04-01 |
| Last updated | 2026-07-17 |
| Official title | Peroxisome Proliferator-Activated Receptor Agonists to Prevent Primary Sclerosing Cholangitis Recurrence After Liver Transplantation |
| ClinicalTrials.gov ID | NCT06905054 |
Interventions
- Fenofibrate (drug) (Drug)
Once daily fenofibrate for 36 months - Blood draw for the laboratory assessment (Diagnostic Test)
Serum assessments will be performed every 3 months during the study period - MRI using a hepatobiliary phase contrast agent (Gd-EOB-DPTA) (Diagnostic Test)
Participants will undergo a quantitative gadoxetate-enhanced MRI and MRCP at baseline, and at 12 months and 36 months of trial participation.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale, Arizona | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.