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

Primary Sclerosing Cholangitis Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Cholestasis
• Primary Sclerosing Cholangitis

• NCT number: NCT04309773
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Olivier CHAZOUILLERES, professor
• Phone: + 33149282380
• Email: olivier.chazouilleres@aphp.fr
• Status: Recruiting
• Phase: Phase 3
• Start date: April 6, 2021
• Completion date: March 2025