drugset / Trial / NCT04751188

A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis

NCT04751188

Phase 3 Unknown 11 enrolled Mexican Social Security Institute
RandomizedParallel-groupTriple-blindTreatment

Summary

Up to 40% of patients with PBC have an inadequate response to standard treatment with Ursodeoxycholic Acid (UDCA), those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. The main objective of the study is to evaluate safety and efficacy of bezafibrate plus ursodesoxicolic acid in patients with PBC and inadequate response to UDCA.

Timeline

Start
2020-10-02
Primary completion
2021-06
Completion
2021-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Bezafibrate Small molecule 200 mg Oral
Background Ursodeoxycholic Acid Small molecule