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

NCT04751188 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2021-02-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Instituto Mexicano del Seguro Social

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-02
Primary Completion
2021-06-30
Completion
2021-07-31

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04751188 on ClinicalTrials.gov