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New treatment option for Primary Biliary Cholangitis (PBC)
Official title FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy
ClinicalTrials.gov ID: NCT07296458
What this study is testing
What is Fenofibrate?
Fenofibrate is an investigational medicine, being studied as a potential treatment for primary biliary cholangitis (pbc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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...
You likely can't join if
- Combined liver diseases caused by other factors: including viral hepatitis, chronic alcoholic hepatitis, steatohepatitis, drug-induced hepatitis...
- Pregnant women, lactating women, or those who plan to give birth during the study period;
- 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...
- Individuals with a history of severe diseases or functional failures in the heart, cerebrovascular system, kidneys, respiratory system, as well as...
- Transaminase greater than 5×ULN, or total bilirubin greater than 3×ULN;
See the full eligibility criteria
- 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...
- 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).
- Combined liver diseases caused by other factors: including viral hepatitis, chronic alcoholic hepatitis, steatohepatitis, drug-induced hepatitis, autoimmune hepatitis, primary sclerosing cholangitis, etc;
- Pregnant women, lactating women, or those who plan to give birth during the study period;
- 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);
- 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);
- people 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 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;
- 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;
- Other situations that researchers judge as unsuitable for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shaanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi'an, Shaanxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.