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Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders

NCT02937012 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2018-04-23

No results posted yet for this study

Summary

The primary biliary cholangitis (PBC), formerly known as primary biliary cirrhosis, treatment is based in the use of ursodeoxycholic acid (UDCA) at a daily dose of 13 to 15 mg/kg, without other treatment options. Patients with good or complete response to UDCA have more liver transplant-free survival and delay histologic progression compared to patients with partial or no response. Nowadays there is an estimated partial response to UDCA in approximately 30 to 50% of patients with PBC. There is a need for new second line management strategies for patients without a biochemical response to UDCA.

The addition of bezafibrate to the treatment of PBC patients with partial biochemical response to UDCA, will increase the biochemical response and improve the long term prognosis? And if so, which are the efficacy and security of bezafibrate in PBC patients without biochemical response?

Conditions

  • Primary Biliary Cirrhosis

Interventions

DRUG

Bezafibrate

Bezafibrate 200 mg manufactured in a pill/capsule presentation

DRUG

Ursodeoxycholic Acid

The patients will continue with the administration of ursodeoxycholic acid at a dose of 13 to 15 mg per Kg per day throughout the study

DRUG

Placebo (for Bezafibrate)

Starch pill/capsule manufactured to mimic bezafibrate 200 mg tablet

Sponsors & Collaborators

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    lead OTHER

Principal Investigators

  • Edgardo Eric Lopez Mendez, MD · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2019-04-30
Completion
2019-12-31

Countries

  • Mexico

Study Locations

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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 NCT02937012 on ClinicalTrials.gov