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

Phase 3

• Conditions: Primary Biliary Cirrhosis
• Interventions: Drug: Bezafibrate 200 MG Oral Tablet; Drug: Placebo; Drug: Ursodeoxycholic Acid

• Registration Number: NCT04751188
• Lead Sponsor: Instituto Mexicano del Seguro Social

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-02
• Status Verified: 2021-02
• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-09
• Last Update Submitted: 2021-02-09
• Study First Posted: 2021-02-12
• Last Update Posted: 2021-02-12
• Primary Completion: 2021-06
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 11

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bezafibrate and Ursodeoxycholic acid	Bezafibrate 200 MG Oral Tablet	Bezafibrate 200 mg every 12 hours and ursodeoxycholic acid at a dose of 13 to 15 mg per Kg per day, for 6 months.
Placebo and Ursodeoxycholic acid	Placebo	Placebo tablet every 12 hours and ursodeoxycholic acid at a dose of 13 to 15 mg per Kg per day, for 6 months.
Bezafibrate and Ursodeoxycholic acid	Ursodeoxycholic Acid	Bezafibrate 200 mg every 12 hours and ursodeoxycholic acid at a dose of 13 to 15 mg per Kg per day, for 6 months.
Placebo and Ursodeoxycholic acid	Ursodeoxycholic Acid	Placebo tablet every 12 hours and ursodeoxycholic acid at a dose of 13 to 15 mg per Kg per day, for 6 months.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Instituto Mexicano de Seguro Social; 🇲🇽 Puebla, Mexico