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Completed

NCT Number: NCT01772121

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

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

Prevalence of Host and Viral Genotypes in Patients With Chronic Hepatitis B and Hepatitis C Infection in India

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 21, 2013
Registry last updated
Jul 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.