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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 17, 2025 to Dec 15, 2025
    • Site details revised
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07296458
Lead Sponsor Xijing Hospital of Digestive Diseases
Conditions
(from sponsor)
Primary Biliary Cholangitis (PBC)
Related terms Liver Cirrhosis, Biliary
Enrollment 132 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov