drugset
drugset / Trial / NCT04309773

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

NCT04309773 ↗

Phase 3 Unknown 104 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupTriple-blindTreatment

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

Timeline

Start
2021-04-06
Primary completion
2023-03
Completion
2025-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Bezafibrate Small molecule 400 mg Oral
Background Ursodeoxycholic Acid Small molecule 15 mg/kg Oral
Background Ursodeoxycholic Acid Small molecule 20 mg/kg Oral

Indications

cholestasis primary sclerosing cholangitis