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Could a common drug stop a rare liver disease from returning after transplant?
NCT ID NCT06905054
First seen Jul 17, 2026 · Last updated Jul 17, 2026
Summary
This study tests whether taking fenofibrate once daily for three years can prevent primary sclerosing cholangitis (PSC) from coming back after a liver transplant. The trial enrolls adults who had a liver transplant for PSC within the past 1 to 7 years and are at higher risk of recurrence. Participants receive fenofibrate and undergo regular blood tests and special MRI scans to monitor for signs of PSC recurrence, compared to a historical group that did not receive the drug.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a drug called fenofibrate, taken once daily for 36 months
- What this could lead to
- If it works, this could offer a way to prevent PSC from returning after a liver transplant, potentially reducing the need for repeat transplants.
- What could go wrong
- This is a Phase 2 trial with only 80 participants, comparing results to a historical control group rather than a placebo, which may limit reliability. Fenofibrate may also cause side effects like muscle pain or liver enzyme changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mayo Clinic in Arizona
RECRUITINGScottsdale, Arizona, 85259, United States
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