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

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ClinicalTrials.gov Identifier: NCT01772121
Recruitment Status : Completed
First Posted : January 21, 2013
Last Update Posted : July 9, 2015
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:
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

Condition or disease
Hepatitis B Hepatitis C

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
Study Design
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Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Host and Viral Genotypes in Patients With Chronic Hepatitis B and Hepatitis C Infection in India
Study Start Date : May 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

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Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
A portion of the blood drawn at the study visits will be frozen and stored. Stored blood samples may be used by the Sponsor or its research partners for HCV/HBV genotyping/phenotyping assays (as applicable) or their development or for retesting the amount of HCV/HBV in the blood. At the conclusion of this study, these samples may be retained in storage by Gilead Sciences or a designee for a period up to 10 years

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
A total of 1000 subjects will be enrolled in the study. Of these, it is planned that approximately 500 subjects will have a diagnosis of chronic HCV infection and approximately 500 subjects will have a diagnosis of chronic HBV infection.Subjects knowingly co-infected with HCV/HBV or HIV may not participate in the study
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772121


Locations
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Sponsors and Collaborators
Gilead Sciences
More Information
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01772121    
Other Study ID Numbers: GX-US-174-0196
First Posted: January 21, 2013    Key Record Dates
Last Update Posted: July 9, 2015
Last Verified: July 2015
Keywords provided by Gilead Sciences:
HBV, HCV, chronic, India, observational study, prevalence,
genotypes, SNPs, viral hepatitis
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic