Actively Recruiting
FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy
Led by Xijing Hospital of Digestive Diseases · Updated on 2025-12-29
132
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily join the study and understand and sign the informed consent form
- Age between 18 and 75 years old
- Diagnosed with Primary Biliary Cholangitis following AASLD guidelines (meeting two of these: positive AMA or gp210, sp100; elevated serum ALP; pathological evidence of non-suppurative cholangitis and bile duct destruction)
- No treatment with UDCA or fenofibrate in the past 6 months and ALP above the upper limit of normal
You will not qualify if you...
- Having other liver diseases such as viral hepatitis, alcoholic hepatitis, steatohepatitis, drug-induced hepatitis, autoimmune hepatitis, or primary sclerosing cholangitis
- Being pregnant, breastfeeding, or planning pregnancy during the study
- Allergy to fenofibrate or ursodeoxycholic acid
- History or presence of serious liver complications like variceal bleeding, hepatic encephalopathy, ascites, spontaneous bacterial peritonitis, hepatocellular carcinoma, or hepatorenal syndrome
- Severe heart, brain, kidney, lung diseases, or mental illnesses including those from alcohol or drug abuse
- Transaminase levels more than 5 times the upper limit of normal or total bilirubin more than 3 times the upper limit
- Creatinine level over 1.5 times the upper limit of normal
- Glomerular filtration rate less than or equal to 45 mL/min/1.73 m2
- INR greater or equal to 1.5 unless within therapeutic range for anticoagulant therapy
- Treatment with obeticholic acid or other fibrates in the past 6 weeks
- Recent use of colchicine, methotrexate, azathioprine, or systemic hormone therapy for over 2 weeks in the past 2 months
- Current immunosuppressant treatment
- Planned or previous organ transplantation
- History of HIV infection or positive HIV antibody
- History of cancer or anti-tumor treatment within past 2 years
- Any other condition deemed unsuitable by the researchers
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Trial Site Locations
Total: 1 location
1
Xijing Hospital
Xi'an, Shaanxi, China, 710032
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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