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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04751188
Other study ID # R-2020-2101-031
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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
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