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

Primary Biliary Cirrhosis Clinical Trial

Official title:

Safety and Efficacy of Bezafibrate Plus Ursodesoxicolic Acid in Patients With Primary Biliary Cholangitis Without Response

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04751188
• Other study ID #: R-2020-2101-031
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 2, 2020
• Est. completion date: July 2021

Study information

• Verified date: February 2021
• Source: Instituto Mexicano del Seguro Social
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 11
• Est. completion date: July 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangitis
• Liver Cirrhosis, Biliary
• Primary Biliary Cirrhosis

Intervention

Drug:
• Bezafibrate 200 MG Oral Tablet
Bezafibrate one tablet every 12 hours for six months.
• Placebo
Placebo one tablet every 12 hours for six months.
• Ursodeoxycholic Acid
At a dose of 13 to 15 mg per Kg per day.

Locations

Country	Name	City	State
Mexico	Instituto Mexicano de Seguro Social	Puebla

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

Outcome

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