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Fibrate

Fenofibrate for Ischemic Cholangiopathy After Liver Transplant (FICsDCD Trial)

Phase 2

Recruiting

Led By Channa Jayasekera, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

FICsDCD Trial Summary

This trial will study whether a daily medication can prevent a complication during a medical procedure for people who have received transplanted livers from deceased donors.

Who is the study for?

This trial is for patients who've had a liver transplant from a donor after circulatory death and have high alkaline phosphatase levels. It's not for those with certain liver diseases, untreated hepatic artery issues, severe kidney problems, significant other illnesses or psychiatric conditions that could affect the study, or known allergies to fenofibrate.Check my eligibility

What is being tested?

The study tests if taking fenofibrate daily can prevent ischemic cholangiopathy in people who received liver transplants from donors after circulatory death. The goal is to see if this medication improves safety and effectiveness compared to standard care without it.See study design

What are the potential side effects?

Fenofibrate may cause side effects like digestive discomfort, potential liver enzyme changes, muscle pain or weakness, and possible interactions with other drugs. Rarely it can lead to more serious issues such as inflammation of the pancreas or gallstones.

FICsDCD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Tolerability of fenofibrate

Secondary outcome measures

Efficacy of fenofibrate

Safety of fenofibrate

Serum biomarker association with development of IC

Side effects data

From 2019 Phase 3 trial • 551 Patients • NCT03001817

Nasopharyngitis

Angina unstable

100%

80%

60%

40%

20%

Study treatment Arm

Fenofibrate and K-877 Placebo: 40-Week Extension

K-877 and Fenofibrate Placebo: 40-Week Extension

K-877: 12-Week Efficacy

Placebo: 12-Week Efficacy

FICsDCD Trial Design

1Treatment groups

Experimental Treatment

Group I: Recipients of DCD liver transplantsExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fenofibrate

2018

Completed Phase 4

~6500

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,212 Previous Clinical Trials

3,766,890 Total Patients Enrolled

Channa Jayasekera, MDPrincipal InvestigatorMayo Clinic

Media Library

Fenofibrate (Fibrate) Clinical Trial Eligibility Overview. Trial Name: NCT05514119 — Phase 2

Liver Transplant Research Study Groups: Recipients of DCD liver transplants

Liver Transplant Clinical Trial 2023: Fenofibrate Highlights & Side Effects. Trial Name: NCT05514119 — Phase 2

Fenofibrate (Fibrate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05514119 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are taking part in this clinical research?

"That is right, the online information hosted on clinicaltrials.gov indicates that this study is still looking for participants. The trial was first announced on 8/17/2022 and was last updated a week ago on 8/23/2022. So far, 1 site has recruited 148 patients."

Answered by AI

Are we still looking for more participants for this research?

"The clinicaltrials.gov website reports that this study is currently looking for patients to enroll. The trial was first advertised on August 17th, 2022 and the listing was last updated on August 23rd, 2022."

Answered by AI

Does Fenofibrate carry a high risk for negative side effects?

"Fenofibrate's safety is estimated to be a 2. This is due to it only being in Phase 2 trials, where there is some data supporting safety, but no evidence yet of efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Channa R Jayasekera, MD, MSc 2022. "A Study to Assess the Role of Fenofibrate in Preventing Ischemic Cholangiopathy After Liver Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05514119.

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