Fenofibrate compared with UDCA as first treatment for primary biliary cholangitis
Compares fenofibrate with UDCA in adults with primary biliary cholangitis not yet treated.
Plain-language title generated from the registry record
Registry title: FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy
Key facts
- Where
- Guangzhou and Xi'an, ChinaSee the 2 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with primary biliary cholangitis (PBC), a liver disease, who have not been treated before and whose ALP blood level is above normal.
- Age
- 18 years or older and younger than 75 years.
- Sex
- All sexes can join.
- Disease stage
- PBC diagnosed by the AASLD guidelines (two of three: positive AMA or gp210, sp100; raised ALP; bile duct damage on biopsy). ALP above the upper limit of normal.
- Earlier treatment
- No UDCA or fenofibrate in the 6 months before joining.
- Biomarker or test result
- ALP above the upper limit of normal (ULN). Positive AMA or gp210, sp100 is one way to meet the diagnosis.
Main reasons for not taking part
- Other liver diseases, such as viral hepatitis or autoimmune hepatitis
- Pregnant or breastfeeding women, or women planning to give birth during the study
- Allergy to fenofibrate or ursodeoxycholic acid
- History of variceal bleeding, hepatic encephalopathy, ascites or liver cancer
- HIV infection, or past or planned organ transplant
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07296458, who can take part
Where in China
- Sun Yat-sen Memorial HospitalGuangzhou, ChinaTaking people
- Xijing hospitalXi'an, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xijing Hospital of Digestive Diseases
- Trial code
- NCT07296458
- Record updated
- 2 November 2026
- Original 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:Read full original descriptionShow less
A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Clinical Trial of Fenofibrate in Treatment-Naïve Patients With Primary Biliary Cholangitis
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).
Inclusion: Voluntarily join the group and be able to understand and sign the informed consent form; Age: 18 years old or above and below 75 years old; 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); 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: 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; Screening for individuals who have taken colchicine, methotrexate, azathioprine, or undergone systemic hormone therapy for more than 2 weeks within the previous 2 months; Is currently undergoing treatment with immunosuppressants (such as cyclosporine, tacrolimus, and related biologics); Plan to receive organ transplantation or have already undergone organ transplantation; Combined liver diseases caused by other factors: including viral hepatitis, chronic alcoholic hepatitis, steatohepatitis, drug-induced hepatitis, autoimmune hepatitis, primary sclerosing cholangitis, etc; Individuals who are allergic to fenofibrate or ursodeoxycholic acid; 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; 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); Clear history of HIV infection or HIV antibody positive during the screening period; Screen for individuals with a clear history of malignant tumor or anti-tumor treatment within the previous 2 years; Transaminase greater than 5×ULN, or total bilirubin greater than 3×ULN; Creatinine level greater than 1.5×ULN; Glomerular filtration rate (GFR) ≤ 45 mL/min/1.73 m2; International normalized ratio (INR) ≥ 1.5 (for patients undergoing anticoagulant therapy, an INR value within the therapeutic target range is sufficient); Pregnant women, lactating women, or those who plan to give birth during the study period; Other situations that researchers judge as unsuitable for enrollment.