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Biliverdin Reductase A in Chronic Hepatitis C Virus Infection

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ClinicalTrials.gov Identifier: NCT01112033
Recruitment Status : Completed
First Posted : April 28, 2010
Last Update Posted : August 7, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Hepatitis C, Chronic

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 Design

Study Type : Observational
Actual Enrollment : 113 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Biliverdin Reductase A in Chronic Hepatitis C Virus Infection
Study Start Date : June 2010
Primary Completion Date : March 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

chronic HCV infection
The study was performed on therapeutically naïve patients with chronic HCV infection. Patients with positivity of anti-HCV antibodies, and detectable HCV RNA in serum for at least 6 months, were included in the study.

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. To analyze the association of genetic polymorphisms of BLVRA with disease progression and treatment response in HCV infected patients. [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
peripheral blood, liver biopsy

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Estimated enrollment: BLVRA expression study: 50 - 100 HCV patients 50 healthy volunteers Polymorphisms of BLVRA study: 300 HCV patients

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112033

Czech Republic
Institute of Clinical Biochemistry and Laboratory Diagnostics, First Faculty of Medicine, Charles University in Prague
Prague, Czech Republic, 128 60
Sponsors and Collaborators
Charles University, Czech Republic
Military University Hospital, Prague
General University Hospital, Prague
Institute for Clinical and Experimental Medicine
Principal Investigator: Iva Subhanova Charles University
More Information

Responsible Party: Iva Subhanova, Institute of Medical Biochemistry and Laboratory Diagnostics, Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT01112033     History of Changes
Other Study ID Numbers: BLVRA1
First Posted: April 28, 2010    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: August 2015

Keywords provided by Iva Subhanova, Charles University, Czech Republic:
biliverdin reductase
hepatitis C
peripheral blood mononuclear cells
genetic polymorphisms

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections