A Study to Assess the Role of Fenofibrate in Preventing Ischemic Cholangiopathy After Liver Transplantation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-17

Study Completion Date

2024-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the safety and effectiveness of a once-daily medication, fenofibrate (Lofibra), to prevent ischemic cholangiography (IC) in persons who were transplanted with livers donated after circulatory death (DCD).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation

NCT06905054

Primary Sclerosing Cholangitis Liver Transplant, Complications PSC +1 more

RECRUITING PHASE2

Use of Fenofibrate for Primary Biliary Cirrhosis

NCT00575042

Primary Biliary Cirrhosis

COMPLETED PHASE2

Deciphering the Mechanisms Involved in Microbial Translocation Across the Spectrum of HCV Associated Liver Fibrosis

NCT02400216

Cirrhosis

COMPLETED

Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male Subjects

NCT05737433

NASH With Fibrosis

COMPLETED EARLY_PHASE1

Insulin Resistance in Non-alcoholic Fatty Liver Disease

NCT00252499

Fatty Liver Insulin Resistance

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this prospective pilot study, we aim to evaluate 1) the tolerability and safety, 2) the efficacy of 12 weeks once-daily fenofibrate in reducing IC incidence after DCD liver transplantation, 3) assess the association between serum markers of cholestasis and development of IC.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Transplant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Recipients of DCD liver transplants

Subjects that have undergone transplant of a liver donation after circulatory death (DCD) in the last 21-35 days will receive a 12 week fenofibrate (Lofibra) for a duration of 12 weeks

Group Type EXPERIMENTAL

Fenofibrate

Intervention Type DRUG

160mg once daily orally for 12 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fenofibrate

160mg once daily orally for 12 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lofibra

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No