Observational Study on Prevalence of Host and Viral Genotypes in Chronic Hepatitis B and Hepatitis C Patients in India

Overview

This study will define the substantial disease burden associated with viral hepatitis in India, and provide a foundation to understand the host and viral determinants of disease pathogenesis that may ultimately impact treatment decisions and outcome

Full Title of Study: “Prevalence of Host and Viral Genotypes in Patients With Chronic Hepatitis B and Hepatitis C Infection in India”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 2012

Detailed Description

The overall goal of this study is to correlate the host and viral genetics of patients infected with viral hepatitis with their clinical presentation. This study will provide the first nation-wide estimate of key host genetic polymorphisms associated with immune response, such as in the IL28B gene locus which has been associated with treatment outcomes in hepatitis C. Characterization of HCV and HBV viral genotypes and sub-types across different geographic regions will allow for an exploration of associations between host and viral genotypes. Another objective of this study is to identify co-morbid illness and metabolic factors that are associated with chronic liver disease due to viral hepatitis. Finally, this survey will explore patient awareness of their disease, risk factors for disease progression, and their treatment options

Arms, Groups and Cohorts

  • HCV Cohort
    • A total of 1000 subjects were enrolled in the study and of that 500 subjects had a diagnosis of chronic HCV infection
  • HBV Cohort
    • A total of 1000 subjects were enrolled in the study and of that 500 subjects had a diagnosis of chronic HBV infection

Clinical Trial Outcome Measures

Primary Measures

  • Variation in the IL28B rs12979860 SNP
    • Time Frame: One Visit
    • Characterize the variation in the IL28B rs12979860 SNP that exists among patients with chronic hepatitis C or chronic hepatitis B infection, in the different geographic regions of India

Secondary Measures

  • Prevelance of HBV and HCV genotypes
    • Time Frame: One Visit
    • Assess the prevalence of HBV and HCV genotypes and subtypes in different geographic regions of India
  • Characterize the SNPs present in innate immune factors toll-like receptor 7 (TLR7)
    • Time Frame: One Visit
    • Characterize the SNPs present in innate immune factors TLR7 (rs3853839, rs179008); TLR9 (rs41308230, rs5743844 ); RIG-I (rs11795404, rs10813831) and NOD2 (rs2067085, rs2066842), in patients with chronic hepatitis C or chronic hepatitis B in the different geographic regions of India

Participating in This Clinical Trial

Inclusion Criteria

  • Willing and able to provide written informed consent
  • Male or female, age >= 18
  • Willing and able to comply with the visit procedure
  • Prior diagnosis of chronic HCV infection or chronic HBV infection

Exclusion Criteria

  • History of difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
  • History of bleeding disorder
  • Blood loss requiring transfusion or > 3 g/dL decrease in hemoglobin within 4 days of the visit
  • Knowingly co-infected with HCV/HBV or with HIV
  • Currently undergoing therapy for chronic hepatitis C or chronic hepatitis B
  • Currently receiving treatment with any other investigational agent or device – Enrolled in another clinical study evaluating a treatment or procedure

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Gilead Sciences
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.