Biliverdin Reductase A in Chronic Hepatitis C Virus Infection

NCT01112033 | Completed

• 1 other identifier: BLVRA1
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C, Chronic

Keywords

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

Outcome Measures

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.

  72 weeks

Secondary Outcomes (1)

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

  3 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Military University Hospital, Prague: collaborator
• General University Hospital, Prague: collaborator
• Institute for Clinical and Experimental Medicine: collaborator

Study Sites (1)

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

Prague, 128 60, Czechia

Location

Related Publications (1)

• 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.

  PMID: 23536765 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood, liver biopsy

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Iva Subhanova

  Charles University, Czech Republic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Institute of Medical Biochemistry and Laboratory Diagnostics

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: April 28, 2010
• Study Start: June 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 7, 2015

Record last verified: 2015-08

Locations

CZ (1)