NCT04309773

Efficacy of 24 Month of Bezafibrate in Primary Sclerosing Cholangitis With Persistent Cholestasis Despite Ursodeoxycholic Acid Therapy

Double Blind, Multicentric, Randomized, Placebo-controlled Trial, Evaluating the Efficacy of 24 Month of Bezafibrate in Primary Sclerosing Cholangitis With Persistent Cholestasis Despite Ursodeoxycholic Acid Therapy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to evaluate the effect of bezafibrate treatment compared to placebo on efficacy and safety in patients with primary sclerosing cholangitis (PSC) and persistent cholestasis despite ursodeoxycholic acid therapy

Detailed description

This is a Phase 3, randomized, double-blind, placebo-controlled, evaluation of the efficacy and safety of Bezafibrate in subjects with PSC and persistent cholestasis despite ursodeoxycholic acid therapy (UADC). Design: * A multicentre, double-blind placebo controlled, randomised clinical trial * 35 centers participants to the recruitment (French Network of Reference and Competence Centers for Rare Diseases: "inflammatory biliary diseases and autoimmune hepatitis" (MIVBH), including Saint-Antoine hospital, Paris as reference coordinator center) Sample size : 104 patients, 52 in each group Treatments groups: 1. UADC therapy (15-20 mg/kg/d) + Bezafibrate (400mg/d) 2. UDCA therapy (15-20 mg/kg/d) + placebo of bezafibrate (400mg/d) Treatments duration : 24 months Assessement: Study visits at Inclusion, (M0) Randomisation and then every 3 months until M24 This is a phase III randomized, double blinded, multicenter, study. No interim analysis is planned. Analysis will be performed at the end of the study after data review and freezing of data base according to intent to treat principle.

Conditions

• Primary Sclerosing Cholangitis
• Cholestasis

Interventions

Type	Name	Description
DRUG	Bezafibrate (400mg) in addition to standard 15-20 mg/kg/jour UDCA therapy	Bezafibrate (400mg) in addition to standard 15-20 mg/kg/jour UDCA therapy Treatment duration : 24 months Bezafibrate/AUDC : daily oral dose
DRUG	Placebo of Bezafibrate in addition to standard UDCA therapy	Placebo of Bezafibrate (400mg) in addition to standard 15-20 mg/kg/Day UDCA therapy Treatment duration : 24 months Placebo/AUDC : daily oral dose

Timeline

• Start date: 2021-04-06
• Primary completion: 2023-03-01
• Completion: 2025-03-01
• First posted: 2020-03-16
• Last updated: 2022-05-10

Locations

1 site across 1 country: France