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CompletedNCT01112033Updated Aug 7, 2015

Biliverdin Reductase A in Chronic Hepatitis C Virus Infection

An observational study in Hepatitis C, Chronic, sponsored by Charles University, Czech Republic. Completed at 1 site in Czechia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-07.

Sponsored by Charles University, Czech Republic · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
113
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Hepatitis C, Chronic

Keywords

  • biliverdin reductase
  • BLVRA
  • hepatitis C
  • HCV
  • peripheral blood mononuclear cells
  • PBMC
  • liver
  • genetic polymorphisms
03

In context

Hepatitis C, Chronic

1,090 studies on the registry are indexed under Hepatitis C, Chronic; 9 are open to participants now.

This study's enrollment of 113 is below the median of 250 across 247 observational studies indexed under Hepatitis C, Chronic.

Browse Hepatitis C, Chronic studies →

Lead sponsor

Charles University, Czech Republic is the lead sponsor of 227 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Co-infection with HAV, HBV and HIV
  • Disorders of heme metabolism
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
113 participants (actual)
Biospecimen retention
Samples with dna

Groups and 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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. To analyze the association of genetic polymorphisms of BLVRA with disease progression and treatment response in HCV infected patients.

    Time frame: 3 years

07

Study locations

1 site
  • Institute of Clinical Biochemistry and Laboratory Diagnostics, First Faculty of Medicine, Charles University in Prague
    Prague, 128 60, Czechia
08

References and documents

Publications

  • 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. PubMed 23536765 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01112033
Collaborators
Military University Hospital, Prague, General University Hospital, Prague, Institute for Clinical and Experimental Medicine
Responsible party
Iva Subhanova (Institute of Medical Biochemistry and Laboratory Diagnostics, Charles University, Czech Republic) — Principal investigator
First posted
Apr 28, 2010
Start date
Jun 2010
Primary completion
Mar 2013
Completion
Jun 2013
Last update
Aug 7, 2015

Study contacts

Iva Subhanova
principal investigator · Charles University, Czech Republic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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