Biliverdin Reductase A in Chronic Hepatitis C Virus Infection

NCT ID: NCT01112033

Last Updated: 2015-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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Hepatitis C, Chronic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Military University Hospital, Prague

OTHER

Sponsor Role collaborator

General University Hospital, Prague

OTHER

Sponsor Role collaborator

Institute for Clinical and Experimental Medicine

OTHER_GOV

Sponsor Role collaborator

Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Iva Subhanova

Institute of Medical Biochemistry and Laboratory Diagnostics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Iva Subhanova

Role: PRINCIPAL_INVESTIGATOR

Charles University

Locations

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Institute of Clinical Biochemistry and Laboratory Diagnostics, First Faculty of Medicine, Charles University in Prague

Prague, , Czechia

Site Status

Countries

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Czechia

References

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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.

Reference Type RESULT
PMID: 23536765 (View on PubMed)

Other Identifiers

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BLVRA1

Identifier Type: -

Identifier Source: org_study_id

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