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Active, not recruiting Early Phase 1

Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)

NCT07104201 · tracked via the Priya Life Science China tracker
Phase
Early Phase 1
Started
2025-03-13
Last updated
2026-07-29

Condition(s) studied

Primary Biliary Cholangitis (PBC)

Investigational drug(s) / intervention(s)

Fenofibrate →

Fenofibrate: Fenofibrate 200mg

Study summary

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Must have provided written informed consent * Age 18-75 years; * BMI 17-28 kg/m2 * Completed in a PBC study with fenofibrate(NCT06591455) Exclusion Criteria: * Coexisting liver disease of other etiologies, including viral hepatitis, chronic alcoholic hepatitis, drug-induced hepatitis, autoimmune hepatitis, hepatocellular carcinoma, etc.; * Transaminases \>5 x ULN or total bilirubin \>3 x ULN; * Pregnant or breastfeeding women, or women planning to conceive during the study period; * Allergy to fenofibrate or ursodeoxycholic acid; * Use of hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months before screening, or long-term corticosteroid use; * Variceal bleeding, hepatic encephalopathy, or ascites at diagnosis or previously; * History of severe cardiac, cerebrovascular, renal, or respiratory disease or failure, or psychiatric illness (including psychiatric illness caused by alcohol or drug abuse); * Creatinine \>1.5 x ULN and creatinine clearance \<60 mL/min; * Current use of statins (e.g., pravastatin, fluvastatin, simvastatin), other fibrates (e.g., gemfibrozil, bezafibrate), or structurally related drugs (e.g., ketoprofen); * Planned organ transplantation or previous organ transplantation; * Need for liver transplantation within 1 year according to the Mayo risk score; * Any other condition considered unsuitable for enrollment by the investigator.

Primary outcome measure(s)

  • Treatment emergent adverse events (TEAEs) — Through study completion, up to 120 Months

Trial sites (1)

FacilityCityRegionStatus
Xijing Hospital Xi'an Shaanxi
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07104201 on ClinicalTrials.gov ↗ ← All trials in China