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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04751188

Enrollment

Registered

2021-02-12

Start date

2020-10-02

Completion date

2021-07-31

Last updated

2021-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Biliary Cirrhosis

Keywords

ursodeoxycholic acid, Bezafibrate

Brief 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.

Interventions

DRUGBezafibrate 200 MG Oral Tablet

Bezafibrate one tablet every 12 hours for six months.

DRUGPlacebo

Placebo one tablet every 12 hours for six months.

DRUGUrsodeoxycholic Acid

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Biochemical response	6 months	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.

Secondary

Measure	Time frame	Description
Quality of life	Baseline and 6 months later	Evaluation of quality of life with the Primary Biliary Cholangitis 40 questionnaire
Pruritus intensity	Baseline and 6 months later	Evaluation made by the use of visual analogue scales.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026