Biliverdin Reductase A in Chronic Hepatitis C Virus Infection

Completed

• Conditions: Hepatitis C, Chronic

• Registration Number: NCT01112033
• Lead Sponsor: Charles University, Czech Republic

Brief Summary

In this project, the investigators aim to study the role of biliverdin reductase A (BLVRA) in HCV infected patients prior and during/after standard antiviral therapy in association with viral clearance, disease progression and treatment response and in comparison with healthy subjects.

Detailed Description

1. To analyze biliverdin reductase (BLVRA) expression in the liver of HVC infected patients undergoing liver biopsy followed by standard antiviral treatment (peg-interferon plus ribavirin combination therapy) and patients with other forms of liver diseases undergoing liver biopsy as controls.

2. To analyze BLVRA expression in peripheral blood leukocytes (PBL) of therapeutically naïve HCV patients, during/after standard antiviral therapy and healthy controls.

3. To analyze BVLRA genetic polymorphisms both in HCV infected patients and healthy controls.

Study Timeline

• Study First Submitted: 2010-04-23
• Study First Submitted QC: 2010-04-26
• Study First Posted: 2010-04-28
• Study Start: 2010-06
• Primary Completion: 2013-03
• Study Completion: 2013-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-05
• Last Update Posted: 2015-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

BLVRA expression study

• Therapeutically naïve HCV patients undergoing antiviral treatment with peg-interferon plus ribavirin combination therapy

BLVRA genetic polymorphisms study

• HCV infected patients prior, during, after or without antiviral therapy

Exclusion Criteria

• Co-infection with HAV, HBV and HIV
• Disorders of heme metabolism

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess differences in BLVRA expression in the liver and PBMC in HCV infected patients in responders and non-responders to standard antiviral therapy.	72 weeks

Secondary Outcome Measures

Name	Time	Method
To analyze the association of genetic polymorphisms of BLVRA with disease progression and treatment response in HCV infected patients.	3 years

Trial Locations

Locations (1)

Institute of Clinical Biochemistry and Laboratory Diagnostics, First Faculty of Medicine, Charles University in Prague; 🇨🇿 Prague, Czech Republic