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

Last updated: February 9, 2021
Sponsor: Instituto Mexicano del Seguro Social
Overall Status: Active - Not Recruiting

Phase

3

Condition

Liver Disease

Gall Bladder Disorders

Primary Biliary Cholangitis

Treatment

N/A

Clinical Study ID

NCT04751188
R-2020-2101-031
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 smallor medium- sized bile ducts.
  • Use of ursodeoxycholic acid (UDCA) for at least 12 months at enrollment at atherapeutic dose (13 to 15 mg per Kg per day).
  • Evidence of a suboptimal biochemical response to UDCA, defined by the presence of oneof the Paris II criteria.
  • Written informed consent.
  • Age ≥ 18 years.

Exclusion

Exclusion Criteria:

  • Hepatic decompensation (ascitis, variceal upper gastrointestinal bleeding, hepaticencephalopathy).
  • Coexistence autoimmune hepatitis.
  • Bilirrubin >3mg/dl.
  • For females, pregnancy or breast-feeding.
  • Hepatocellular carcinoma.
  • History or presence of spontaneous bacterial peritonitis.

Study Design

Total Participants: 11
Study Start date:
October 02, 2020
Estimated Completion Date:
July 31, 2021

Connect with a study center

  • Instituto Mexicano de Seguro Social

    Puebla, 72000
    Mexico

    Site Not Available

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