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

• ClinicalTrials.gov Identifier: NCT04751188
• Recruitment Status: Active, not recruiting
• First Posted: February 12, 2021
• Last Update Posted: February 12, 2021
• Sponsor: Instituto Mexicano del Seguro Social
• Information provided by (Responsible Party): Jocelyn Serrano Casas, Instituto Mexicano del Seguro Social

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Primary Biliary Cirrhosis	Drug: Bezafibrate 200 MG Oral Tablet; Drug: Placebo; Drug: Ursodeoxycholic Acid	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Bezafibrate Plus Ursodesoxicolic Acid in Patients With Primary Biliary Cholangitis Without Response
• Actual Study Start Date: October 2, 2020
• Estimated Primary Completion Date: June 2021
• Estimated Study Completion Date: July 2021

Arms and Interventions

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: Placebo; Placebo one tablet every 12 hours for six months.; Drug: Ursodeoxycholic Acid; At a dose of 13 to 15 mg per Kg per day.

Outcome Measures

Primary Outcome Measures :

1. Biochemical response [ Time Frame: 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 :

1. Quality of life [ Time Frame: Baseline and 6 months later ]
   Evaluation of quality of life with the Primary Biliary Cholangitis 40 questionnaire
2. Pruritus intensity [ Time Frame: Baseline and 6 months later ]
   Evaluation made by the use of visual analogue scales.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Mexico

Instituto Mexicano de Seguro Social

Puebla, Mexico, 72000

Sponsors and Collaborators

Instituto Mexicano del Seguro Social

More Information

• Responsible Party: Jocelyn Serrano Casas, Principal Investigator, Instituto Mexicano del Seguro Social
• ClinicalTrials.gov Identifier: NCT04751188
• Other Study ID Numbers: R-2020-2101-031
• First Posted: February 12, 2021
• Last Update Posted: February 12, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Jocelyn Serrano Casas, Instituto Mexicano del Seguro Social:

ursodeoxycholic acid; Bezafibrate

Additional relevant MeSH terms:

Cholangitis; Liver Cirrhosis, Biliary; Fibrosis; Pathologic Processes; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholestasis, Intrahepatic; Cholestasis; Liver Diseases; Liver Cirrhosis; Ursodeoxycholic Acid; Bezafibrate; Cholagogues and Choleretics; Gastrointestinal Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents