Biliverdin Reductase A in Chronic Hepatitis C Virus Infection

This study has been completed.
Sponsor:
Collaborators:
Military University Hospital, Prague
General University Hospital, Prague
Institute for Clinical and Experimental Medicine
Information provided by (Responsible Party):
Iva Subhanova, Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT01112033
First received: April 23, 2010
Last updated: August 5, 2015
Last verified: August 2015
  Purpose

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
Hepatitis C, Chronic

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Biliverdin Reductase A in Chronic Hepatitis C Virus Infection

Resource links provided by NLM:


Further study details as provided by Charles University, Czech Republic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To analyze the association of genetic polymorphisms of BLVRA with disease progression and treatment response in HCV infected patients. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

peripheral blood, liver biopsy


Enrollment: 113
Study Start Date: June 2010
Study Completion Date: June 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112033

Locations
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
Investigators
Principal Investigator: Iva Subhanova Charles University
  More Information

Publications:
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
Study First Received: April 23, 2010
Last Updated: August 5, 2015
Health Authority: Czech Republic: Ethics Committee

Keywords provided by Charles University, Czech Republic:
biliverdin reductase
BLVRA
hepatitis C
HCV
peripheral blood mononuclear cells
PBMC
liver
genetic polymorphisms

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

ClinicalTrials.gov processed this record on August 26, 2015