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

Instituto Mexicano del Seguro Social11 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Primary Biliary Cirrhosis

Interventions

Bezafibrate 200 MG Oral TabletDRUG

Bezafibrate one tablet every 12 hours for six months.

PlaceboDRUG

Placebo one tablet every 12 hours for six months.

Ursodeoxycholic AcidDRUG

At a dose of 13 to 15 mg per Kg per day.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * PBC diagnosis (consistent with American Association for the Study of Liver Disease \[AASLD\]: * History of elevated alkaline phosphatase levels. * Anti-mitochondrial antibodies positivity * Histopathologic evidence of nonsuppurative cholangitis and destruction of small or medium- sized bile ducts. * Use of ursodeoxycholic acid (UDCA) for at least 12 months at enrollment at a therapeutic dose (13 to 15 mg per Kg per day). * Evidence of a suboptimal biochemical response to UDCA, defined by the presence of one of the Paris II criteria. * Written informed consent. * Age ≥ 18 years. Exclusion Criteria: * Hepatic decompensation (ascitis, variceal upper gastrointestinal bleeding, hepatic encephalopathy). * Coexistence autoimmune hepatitis. * Bilirrubin \>3mg/dl. * For females, pregnancy or breast-feeding. * Hepatocellular carcinoma. * History or presence of spontaneous bacterial peritonitis.

Locations (1)

Instituto Mexicano de Seguro Social

Puebla City, Mexico

Outcomes

Primary Outcomes

Biochemical response

Biochemical response is defined as the reduction of alkaline phosphatase lower than 1.5 times the upper normal limit, reduction of aspartate transaminase lower than 1.5 times the upper normal limit and bilirubin lower than 1 mg/dl.

Time frame: 6 months

Secondary Outcomes

Quality of life

Evaluation of quality of life with the Primary Biliary Cholangitis 40 questionnaire

Time frame: Baseline and 6 months later

Pruritus intensity

Evaluation made by the use of visual analogue scales.

Time frame: Baseline and 6 months later

Data from ClinicalTrials.gov

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