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

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 study is testing fenofibrate — a commonly used cholesterol-lowering drug — as an add-on treatment for patients with Primary Biliary Cholangitis (PBC) who also have compensated liver cirrhosis and have not responded adequately to standard therapy with ursodeoxycholic acid (UDCA). PBC is a chronic autoimmune liver disease that progressively damages the bile ducts, leading to cirrhosis and, in advanced cases, liver failure. Fenofibrate activates a receptor that may reduce inflammation and bile duct injury, potentially slowing disease progression. To participate, you must be between 18 and 75 years old, have a confirmed PBC diagnosis, have compensated cirrhosis (liver scarring that has not yet caused major liver failure), and have had an incomplete response to UDCA (liver enzymes still elevated after at least 6 months of therapy). People with other liver diseases, liver failure indicators, allergies to fenofibrate or UDCA, recent hepatotoxic drug use, variceal bleeding, or severe heart/kidney disease are not eligible. Participants will receive fenofibrate in addition to their ongoing UDCA therapy and be monitored for liver function improvement. This research is important because PBC patients with cirrhosis who don't respond to UDCA face a high risk of liver failure and need transplant. Finding an effective second-line treatment could significantly extend and improve quality of life for this population.

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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