NCT05749822

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Primary Biliary Cholangitis

Interventions

Type	Name	Description
DRUG	Fenofibrate 200mg	Fenofibrate 200mg/day
DRUG	Placebo	1 tablet/ day
DRUG	UDCA	UDCA 13-15mg/kg/day

Timeline

• Start date: 2023-02-17
• Primary completion: 2027-12-01
• Completion: 2027-12-31
• First posted: 2023-03-01
• Last updated: 2026-01-08

Locations

12 sites across 1 country: China