NCT07296458

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

Recruiting now Phase 3 Last updated 29 December 2025

What this trial tests

Phase 3 trial testing Fenofibrate in Primary Biliary Cholangitis (PBC) in 132 participants. Currently enrolling.

Timeline

15 December 2025

Primary endpoint
31 December 2028

31 December 2028

Quick facts

Lead sponsor	Xijing Hospital of Digestive Diseases
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	132
Start date	15 December 2025
Primary completion	31 December 2028
Estimated completion	31 December 2028
Sites	1 location across China

Drugs / interventions tested

• Fenofibrate (FENOFIBRATE) — full drug profile →
• UDCA (Ursodeoxycholic acid) — full drug profile →

Conditions studied

• Primary Biliary Cholangitis (PBC) — all drugs for Primary Biliary Cholangitis (PBC) →

Sponsor

Xijing Hospital of Digestive Diseases

Who can join

Adults 18 to 75, any sex, with Primary Biliary Cholangitis (PBC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.