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Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis

Primary Biliary Cholangitis Clinical Trial

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

Clinical Trial 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).

Clinical Trial Description

This is a multi-center, randomized, placebo-controlled, parallel-group study that aims to assess the efficacy and safety of fenofibrate in patients with compensated cirrhosis PBC who had an inadequate biochemical response to UDCA. Fenofibrate or placebo 200 mg will be daily administered in combination with UDCA 13-15 mg/kg/d for 12 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05749822
Study type Interventional
Source Xijing Hospital of Digestive Diseases
Contact Yulong Shang
Phone +86-29-84771539
Email shangyl870222@163.com
Status Recruiting
Phase Phase 2/Phase 3
Start date February 17, 2023
Completion date December 31, 2025
View Details
See also
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