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FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy

NCT07296458 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2025-12-29

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if the drug Fenofibrate works to treat adults with a liver disease called Primary Biliary Cholangitis (PBC) who have not received previous treatment. It will also learn about the safety of Fenofibrate. The main questions it aims to answer are:

Is Fenofibrate better at helping the liver return to normal function (measured by a blood test called ALP) than the standard medication, Ursodeoxycholic What kind of medical problems do participants have when taking Fenofibrate compared to those taking UDCA?

Researchers will compare Fenofibrate to the active drug UDCA (the current standard treatment) to see which one works better.\*\*

Participants will:

Be randomly assigned to take either Fenofibrate plus a UDCA placebo, or UDCA plus a Fenofibrate placebo, every day for 12 months. (Neither they nor their doctor will know which group they are in.) Visit the clinic 5 times over the year (at 1, 3, 6, 9, and 12 months) for check-ups, blood tests, and questionnaires.

Undergo a special scan (like FibroScan) to measure liver stiffness at some visits.

Be encouraged to have a liver biopsy at the start and end of the study to provide detailed information about liver health (this is optional).

Conditions

  • Primary Biliary Cholangitis (PBC)

Interventions

DRUG

Fenofibrate

Fenofibrate 200mg+placebo

DRUG

UDCA (Ursodeoxycholic acid)

UDCA13-15mg/kg/day+placebo

Sponsors & Collaborators

  • Xijing Hospital of Digestive Diseases

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07296458 on ClinicalTrials.gov