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
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Condition or disease |
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Hepatitis B Hepatitis C |
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 |

Group/Cohort |
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HCV Cohort
A total of 1000 subjects were enrolled in the study and of that 500 subjects had a diagnosis of chronic HCV infection
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HBV Cohort
A total of 1000 subjects were enrolled in the study and of that 500 subjects had a diagnosis of chronic HBV infection
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- 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
- 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
Biospecimen Retention: Samples With DNA

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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 |
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

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

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 |
HBV, HCV, chronic, India, observational study, prevalence, genotypes, SNPs, viral hepatitis |
Hepatitis A Hepatitis C Hepatitis B Hepatitis B, Chronic Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections |
Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Flaviviridae Infections Hepadnaviridae Infections DNA Virus Infections Hepatitis, Chronic |