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

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 Overview

• Status: Active, not recruiting
• Conditions: Primary Biliary Cirrhosis
• Intervention / Treatment: Drug: Bezafibrate 200 MG Oral Tablet; Drug: Ursodeoxycholic Acid; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 11
• Phase: Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Puebla, Mexico, 72000
    • Instituto Mexicano de Seguro Social

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bezafibrate and 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.	Drug: Bezafibrate 200 MG Oral Tablet; Bezafibrate one tablet every 12 hours for six months.; Drug: Ursodeoxycholic Acid; At a dose of 13 to 15 mg per Kg per day.
Placebo Comparator: Placebo and 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.	Drug: Ursodeoxycholic Acid; At a dose of 13 to 15 mg per Kg per day.; Drug: Placebo; Placebo one tablet every 12 hours for six months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Instituto Mexicano del Seguro Social

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: ursodeoxycholic acid; Bezafibrate
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis, Intrahepatic; Cholestasis; Liver Cirrhosis; Cholangitis; Liver Cirrhosis, Biliary; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gastrointestinal Agents; Hypolipidemic Agents; Lipid Regulating Agents; Cholagogues and Choleretics; Ursodeoxycholic Acid; Bezafibrate
• Other Study ID Numbers: R-2020-2101-031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No