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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Variation in the IL28B rs12979860 SNP | 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 | One Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Prevelance of HBV and HCV genotypes | Assess the prevalence of HBV and HCV genotypes and subtypes in different geographic regions of India | One Visit |
| Characterize the SNPs present in innate immune factors toll-like receptor 7 (TLR7) |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Global Hospitals, Lakdi ka Pul | Hyderabad | Andhra Pradesh | 500004 | India | ||
| Asian Institute of Gastroenterology , 6-3-661, Somajiguda |
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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
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
| One Visit |
| Hyderabad |
| Andhra Pradesh |
| 500082 |
| India |
| Institute of digestive and liver disease,Ganeshguri | Guwahati | Assam | 781 006 | India |
| Liver Clinic, 203-204, Narmada Complex, Near Kadiwala School, Ring Road | Surat | Gujarat | 395002 | India |
| Medanta-The Medicity,Sector - 38 | Gurgaon | Haryana | 122001 | India |
| Manipal Hospitals,98, HAL Airport Road | Bangalore | Karnataka | 560017 | India |
| Diwaliben Mohanlal Mehta Charitable Trust ,1st Foor, Khatau Mansion,95/K Bhulabhai Desai Road | Mumbai | Maharashtra | 400 036 | India |
| Seth GS Medical College and KEM Hospital, Acharya Donde Marg, Parel | Mumbai | Maharashtra | 400012 | India |
| Midas Institute of Gastro-enterology, Midas Height,7 - Central Bazar Road,Ramdaspeth | Nagpur | Maharashtra | 440010 | India |
| Dharamsi Hospital,Chandni Chowk, South Shivajinagar | Sangli | Mahashtra | 416 416 | India |
| Civil Hospital, Dawrpui | Aizawl | Mizoram | India |
| Institute of Liver and Biliary Sciences, D-1, Vasant Kunj | New Delhi | New Delhi | 110070 | India |
| Digestive Diseases Centre, Beam Diagnostics Premises, Bajrakabati Road [Mali Sahi], Bata Lane | Cuttack | Odhisa | 753001 | India |
| Dayanand Medical College & Hospital, Tagore Nagar, Civil Lines | Ludhiana | Punjab | 141001 | India |
| Rai Speciality Care Centre, H-6 Janpath,Shyamnagar,Ajmer Road, Sodala | Jaipur | Rajasthan | 342019 | India |
| Global Hospitals & Health City,# 439, Cheran Nagar, Perumbakkam, Off OMR, Near Shollinganalur | Chennai | Tamil Nadu | 600 100 | India |
| VGM Hospital, 2100, Trichy Road, Rajalakshmi Mills Stop | Coimbatore | Tamil Nadu | 641005 | India |
| Institute of Post Graduate Medical Education And Research,244 A.J.C Bose Road | Kolkata | West Bengal | 700020 | India |
| Apollo Hospital, Seepat Road | Bilāspur | 495006 | India |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D006526 | Hepatitis C |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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