Biliverdin Reductase A in Chronic Hepatitis C Virus Infection

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Charles University, Czech Republic
Sponsor:
Collaborators:
Central Military Hospital, Prague, Czech Republic
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: February 13, 2013
Last verified: February 2013
  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 Virus Infection

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


Estimated Enrollment: 100
Study Start Date: June 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
HCV infected patients

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

Contacts
Contact: Iva Subhanova Iva.Subhanova@seznam.cz
Contact: Libor Vitek, Prof., MD.,PhD. vitek@cesnet.cz

Locations
Czech Republic
Institute of Clinical Biochemistry and Laboratory Diagnostics, First Faculty of Medicine, Charles University in Prague Recruiting
Prague, Czech Republic, 128 60
Contact: Iva Subhanova       Iva.Subhanova@seznam.cz   
Contact: Libor Vitek, Prof.,MD, PhD.       vitek@cesnet.cz   
Principal Investigator: Iva Subhanova         
Sponsors and Collaborators
Charles University, Czech Republic
Central Military Hospital, Prague, Czech Republic
General University Hospital, Prague
Institute for Clinical and Experimental Medicine
Investigators
Principal Investigator: Iva Subhanova Charles University
  More Information

No publications provided

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: February 13, 2013
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, Chronic
Hepatitis C
Virus Diseases
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on July 24, 2014