Status:
COMPLETED
A Pilot Study of Fenofibrate and Ursodeoxycholic Acid in the Treatment of Newly Diagnosed Primary Biliary Cholangitis
Lead Sponsor:
Han Ying
Conditions:
Primary Biliary Cholangitis (PBC)
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief Summary
This study is a prospective, single center, randomized controlled, exploratory clinical trial aimed at evaluating the efficacy and safety of fenofibrate in newly diagnosed PBC subjects.
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 AP above ULN for at least six months;
- Positive 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.
- Not receiving UDCA treatment before enrollment, ALP\>ULN
Exclusion
- History or presence of other concomitant liver diseases.
- ALT or AST \> 5×ULN, 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 :
September 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06591455
Start Date
September 14 2024
End Date
August 18 2025
Last Update
November 28 2025
Active Locations (1)
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1
Xijing hospital
Xi'an, Shaanxi, China, 710032