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Liver transplant drug trial halted early – only 6 patients enrolled

NCT ID NCT05514119

Disease control Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether the drug fenofibrate could prevent a type of bile duct damage called ischemic cholangiopathy in people who received a liver from a donor after circulatory death. Only 6 participants were enrolled before the trial was terminated early. The main goal was to see if patients could tolerate the medication without serious side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fenofibrate (Lofibra), a medication taken as a 160 mg pill once daily for 12 weeks
What this could lead to
If it worked, fenofibrate could help prevent bile duct damage in people who receive a liver from a donor after circulatory death, improving transplant success.
What could go wrong
The trial was terminated early and only enrolled 6 people, so results are very limited. Fenofibrate may cause side effects like kidney issues or rejection, and its benefit is unproven.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

6 people

The number who actually took part.

Started

Aug 2022

Finished

Dec 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients who have undergone Donation after Circulatory Death (DCD) liver transplantation (LT). * At least one serum alkaline phosphatase level \>2.5x upper limit of normal between post-LT days 21-60 (inclusive). Exclusion criteria: * LT performed for primary sclerosing cholangitis or primary biliary cholangitis. * Untreated hepatic artery compromise (e.g thrombosis, stenosis) * Untreated biliary anastomotic stricture or bile leak between days 0-60 after LT * Renal dysfunction defined as baseline glomerular filtration rate \< 30 ml/min. * Previously known intolerance or allergy to fenofibrate. * Other clinically significant comorbid condition, including psychiatric conditions, which in the opinion of the study team, may interfere with patient treatment, safety, assessment, or compliance with the treatment. * Adults lacking capacity to consent to treatment

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Liver transplant

Contacts and locations

Locations

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85254, United States

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