Biliverdin Reductase A in Chronic Hepatitis C Virus Infection

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01112033

Enrollment

113

Registered

2010-04-28

Start date

2010-06-30

Completion date

2013-06-30

Last updated

2015-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic

Keywords

biliverdin reductase, BLVRA, hepatitis C, HCV, peripheral blood mononuclear cells, PBMC, liver, genetic polymorphisms

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Czechia

Outcome results