RecruitingPhase 2Phase 3NCT06365424

Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)

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


Sponsor

Xijing Hospital of Digestive Diseases

Enrollment

117 participants

Start Date

Apr 8, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is a long-term follow-up for patients who previously participated in a clinical trial of fenofibrate (a medication typically used for cholesterol) as a treatment for primary biliary cholangitis (PBC) — a chronic liver disease where the immune system attacks the bile ducts. **You may be eligible if...** - You previously participated in the fenofibrate PBC clinical trial (NCT02823353) - You are using appropriate contraception if you are of reproductive potential **You may NOT be eligible if...** - You had to stop taking fenofibrate in the previous trial due to a treatment-related side effect - You have another medical condition that your doctor believes would prevent you from safely completing this study Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFenofibrate

Fenofibrate (200 mg/day)

DRUGUDCA

Ursodeoxycholic acid (13-15 mg/kg/day)


Locations(1)

Xijing Hospital

Xi'an, Shaanxi, China

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NCT06365424


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