Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT07296458
Eligibility Criteria:
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;
11. Screening for individuals who have taken colchicine, methotrexate, azathioprine, or undergone systemic hormone therapy for more than 2 weeks within the previous 2 months;
12. Is currently undergoing treatment with immunosuppressants (such as cyclosporine, tacrolimus, and related biologics);
13. Plan to receive organ transplantation or have already undergone organ transplantation;
14. Clear history of HIV infection or HIV antibody positive during the screening period;
15. Screen for individuals with a clear history of malignant tumor or anti-tumor treatment within the previous 2 years;
16. Other situations that researchers judge as unsuitable for enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07296458
Study Brief:
Protocol Section:
NCT07296458