Biliverdin Reductase A in Chronic Hepatitis C Virus Infection

Hepatitis C, Chronic Clinical Trial

Official title:

Biliverdin Reductase A in Chronic Hepatitis C Virus Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01112033
• Other study ID #: BLVRA1
• Status: Completed
• Phase: N/A
• First received: April 23, 2010
• Last updated: August 5, 2015
• Start date: June 2010
• Est. completion date: June 2013

Study information

• Verified date: August 2015
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: June 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Virus Diseases

Locations

Country	Name	City	State
Czech Republic	Institute of Clinical Biochemistry and Laboratory Diagnostics, First Faculty of Medicine, Charles University in Prague	Prague

Sponsors (4)

Lead Sponsor	Collaborator
Charles University, Czech Republic	General University Hospital, Prague, Institute for Clinical and Experimental Medicine, Military University Hospital, Prague

Country where clinical trial is conducted

Czech Republic, 

References & 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. 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To analyze the association of genetic polymorphisms of BLVRA with disease progression and treatment response in HCV infected patients.		3 years	No