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Completed

NCT Number: NCT01112033

Biliverdin Reductase A in Chronic Hepatitis C Virus Infection

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Clinical Biochemistry and Laboratory Diagnostics, First Faculty of Medicine, Charles University in Prague

Prague, 128 60, Czechia

About this study

  • 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.
  • To analyze BLVRA expression in peripheral blood leukocytes (PBL) of therapeutically naïve HCV patients, during/after standard antiviral therapy and healthy controls.
  • To analyze BVLRA genetic polymorphisms both in HCV infected patients and healthy controls.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To assess differences in BLVRA expression in the liver and PBMC in HCV infected patients in responders and non-responders to standard antiviral therapy.

    Time frame: 72 weeks

Secondary outcomes

  1. To analyze the association of genetic polymorphisms of BLVRA with disease progression and treatment response in HCV infected patients.

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Collaborators

  • General University Hospital, Prague
  • Institute for Clinical and Experimental Medicine
  • Military University Hospital, Prague

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Apr 28, 2010
Registry last updated
Aug 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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