Status:
ACTIVE_NOT_RECRUITING
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis
Lead Sponsor:
Han Ying
Conditions:
Primary Biliary Cholangitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
The main objectives of the study were to assess the effects of fenofibrate on serum alkaline phosphatase, as a composite endpoint and on safety in participants with primary biliary cholangitis (PBC)
Eligibility Criteria
Inclusion
- Must have provided written informed consent
- Age 18-75 years;
- BMI 17-28 kg/m2
- Male or female with a diagnosis of PBC, by at least two of the following criteria:
- History of alkaline phosphatase（ALP） above upper limit of normal（ULN） for at least six months;
- Positive Anti-mitochondrial antibody (AMA) titers (\>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies;
- Documented liver biopsy result consistent with PBC.
- Incomplete response to UDCA defined by 1 x ULN\< ALP \<= 1.67 x ULN
- Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0
Exclusion
- History or presence of other concomitant liver diseases.
- ALT or AST \> 5×ULN, total bilirubin（TBIL） \> 3×ULN.
- If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.
- Allergic to fenofibrate or ursodeoxycholic acid.
- Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users.
- Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites.
- Patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease or functional failure, and psychiatric disorders (including those due to alcohol and drug abuse).
- Creatinine \>1.5×ULN and creatinine clearance \<60 ml/min.
- Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen).
- Planned to receive an organ transplant or an organ transplant recipient.
- Needing Liver transplantation within 1 year according to the Mayo Rick score.
- Any other condition(s) that would compromise the safety of the subject or compromise
Key Trial Info
Start Date :
August 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT06174402
Start Date
August 21 2023
End Date
December 31 2026
Last Update
January 8 2026
Active Locations (10)
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1
The second hospital of Lanzhou University
Lanzhou, Gansu, China
2
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
3
Jiangsu Province Hospital
Nanjing, Jiangsu, China
4
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China