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Biliverdin Reductase A in Chronic Hepatitis C Virus Infection

This study is currently recruiting participants.
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, Prague, Czech Republic
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
History of Changes

April 23, 2010
February 13, 2013
June 2010
June 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01112033 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Biliverdin Reductase A in Chronic Hepatitis C Virus Infection
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.
  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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

peripheral blood, liver biopsy
Non-Probability Sample

Estimated enrollment: BLVRA expression study: 50 - 100 HCV patients 50 healthy volunteers Polymorphisms of BLVRA study: 300 HCV patients
Hepatitis C Virus Infection
Not Provided
HCV infected patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
June 2014
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact: Iva Subhanova Iva.Subhanova@seznam.cz
Contact: Libor Vitek, Prof., MD.,PhD. vitek@cesnet.cz
Czech Republic
 
NCT01112033
BLVRA1
No
Iva Subhanova, Charles University, Czech Republic
Charles University, Czech Republic
  • Central Military Hospital, Prague, Czech Republic
  • General University Hospital, Prague
  • Institute for Clinical and Experimental Medicine, Prague, Czech Republic
Principal Investigator: Iva Subhanova Charles University
Charles University, Czech Republic
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP