NCT04751188

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

Safety and Efficacy of Bezafibrate Plus Ursodesoxicolic Acid in Patients With Primary Biliary Cholangitis Without Response

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 11 (estimated)
• Sponsor: Instituto Mexicano del Seguro Social · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Biliary Cirrhosis

Interventions

Type	Name	Description
DRUG	Bezafibrate 200 MG Oral Tablet	Bezafibrate one tablet every 12 hours for six months.
DRUG	Placebo	Placebo one tablet every 12 hours for six months.
DRUG	Ursodeoxycholic Acid	At a dose of 13 to 15 mg per Kg per day.

Timeline

• Start date: 2020-10-02
• Primary completion: 2021-06-01
• Completion: 2021-07-01
• First posted: 2021-02-12
• Last updated: 2021-02-12

Locations

1 site across 1 country: Mexico