NCT07296458

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

A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Clinical Trial of Fenofibrate in Treatment-Naïve Patients With Primary Biliary Cholangitis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Fenofibrate	Fenofibrate 200mg+placebo
DRUG	UDCA (Ursodeoxycholic acid)	UDCA13-15mg/kg/day+placebo

Timeline

• Start date: 2025-12-15
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2025-12-22
• Last updated: 2025-12-29

Locations

1 site across 1 country: China