Clinical trial NCT01112033: Biliverdin Reductase A in Chronic Hepatitis C Virus Infection
Official title: Biliverdin Reductase A in Chronic Hepatitis C Virus Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Keywords: biliverdin reductase
BLVRA
hepatitis C
HCV
peripheral blood mononuclear cells
PBMC
liver
genetic polymorphisms
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: Military University Hospital, Prague
name: General University Hospital, Prague
name: Institute for Clinical and Experimental Medicine
First posted: 2010-04-28
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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 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

Primary outcomes:
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.
timeFrame: 72 weeks
Secondary outcomes:
measure: To analyze the association of genetic polymorphisms of BLVRA with disease progression and treatment response in HCV infected patients.
timeFrame: 3 years
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Institute of Clinical Biochemistry and Laboratory Diagnostics, First Faculty of Medicine, Charles University in Prague
Study officials:
affiliation: Charles University
name: Iva Subhanova
role: PRINCIPAL_INVESTIGATOR
References:
citation: Subhanova I, Muchova L, Lenicek M, Vreman HJ, Luksan O, Kubickova K, Kreidlova M, Zima T, Vitek L, Urbanek P. Expression of Biliverdin Reductase A in peripheral blood leukocytes is associated with treatment response in HCV-infected patients. PLoS One. 2013;8(3):e57555. doi: 10.1371/journal.pone.0057555. Epub 2013 Mar 11.