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FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

NCT07296458•Xijing Hospital of Digestive Diseases

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntarily join the group and be able to understand and sign the informed consent form;
•2. Age: 18 years old or above and below 75 years old;
•3. The diagnosis of primary biliary cholangitis follows the AASLD international diagnostic and treatment guidelines (meeting two of the following three criteria: positive AMA or gp210, sp100; elevated serum ALP; pathological manifestations of non-suppurative cholangitis and interlobular bile duct destruction);
•4. The patient did not receive UDCA and fenofibrate treatment in the 6 months before enrollment, and ALP was greater than the upper limit of normal (ULN).

Exclusion Criteria

•1. Combined liver diseases caused by other factors: including viral hepatitis, chronic alcoholic hepatitis, steatohepatitis, drug-induced hepatitis, autoimmune hepatitis, primary sclerosing cholangitis, etc;
•2. Pregnant women, lactating women, or those who plan to give birth during the study period;
•3. Individuals who are allergic to fenofibrate or ursodeoxycholic acid;
•4. At the time of diagnosis or in the past, there have been variceal bleeding, hepatic encephalopathy, ascites, spontaneous bacterial peritonitis, hepatocellular carcinoma, and hepatorenal syndrome;
•5. Individuals with a history of severe diseases or functional failures in the heart, cerebrovascular system, kidneys, respiratory system, as well as mental illnesses (including those caused by alcohol and drug abuse);
•6. Transaminase greater than 5×ULN, or total bilirubin greater than 3×ULN;
•7. Creatinine level greater than 1.5×ULN;
•8. Glomerular filtration rate (GFR) ≤ 45 mL/min/1.73 m2;
•9. International normalized ratio (INR) ≥ 1.5 (for patients undergoing anticoagulant therapy, an INR value within the therapeutic target range is sufficient);
•10. Subjects who have received treatment with obeticholic acid and other fibrates (such as gemfibrozil, bezafibrate, pemafibrate, Elafibranor, Seladelpar, Lanifibranor, Saroglitizar, etc.) within the previous 6 weeks prior to screening;
+6 more criteria

Locations (1)

Xijing Hospital

Xi'an, Shaanxi, China

Key Dates

Start Date

December 15, 2025

Primary Completion Date

December 31, 2028

Completion Date

December 31, 2028

Last Updated

December 29, 2025

Enrollment

132

ESTIMATED participants

Conditions

Primary Biliary Cholangitis (PBC)

Interventions

Fenofibrate

DRUG

UDCA (Ursodeoxycholic acid)

DRUG

A Two-part Study to Investigate the Effects in Adults of Two Doses of Golexanolone in Patients With Primary Biliary Cholangitis (PBC) With Fatigue and Cognitive Dysfunction

NCT07304843

Primary Biliary Cholangitis (PBC)

View study

RECRUITING

Biochemical Response and Clinical Outcomes in Patients With PBC

NCT07449793

Primary Biliary Cholangitis (PBC)Primary Biliary Cholangitis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Two-part Study to Investigate the Effects in Adults of Two Doses of Golexanolone in Patients With Primary Biliary Cholangitis (PBC) With Fatigue and Cognitive Dysfunction

Biochemical Response and Clinical Outcomes in Patients With PBC

Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis: a Real World Study

EMPower Mechanisms

A Multicenter, Randomized, Controlled Trial of Prednisone Combined With Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis With Moderate to Severe Interface Hepatitis Characteristics

PET/CT Scans Using the Tracer 11C-Csar, a Bile Acid Analog, to Depict and Visualize Changes in the Hepatobiliary System in Patients With Primary Biliary Cholangitis Before and After Treatment.