RecruitingPhase 2Phase 3NCT05749822

Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis

Fenofibrate Combined With Ursodeoxycholic Acid in Compensated Cirrhosis Patients With Primary Biliary Cholangitis Who Had an Inadequate Response to Ursodeoxycholic Acid

Sponsor

Xijing Hospital of Digestive Diseases

Enrollment

104 participants

Start Date

Feb 17, 2023

Study Type

INTERVENTIONAL

Conditions

Primary Biliary Cholangitis

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Fenofibrate 200mg, a drug called Placebo, and others for people with primary biliary cholangitis. The study is currently recruiting participants at 12 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFenofibrate 200mg

Fenofibrate 200mg/day

DRUGPlacebo

1 tablet/ day

DRUGUDCA

UDCA 13-15mg/kg/day

Locations(12)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Xiangya Hospital Central South University

Changsha, Hunan, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Xijing Hospital

Xi'an, Shaanxi, China

Yan'an University Affiliated Hospital

Yan’an, Shaanxi, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Tianjin Third Central Hospital

Tianjin, Tianjin Municipality, China

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Tianjin Medical University General Hospital

Tianjin, China

View Full Details on ClinicalTrials.gov

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NCT05749822

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