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

Completed

• Conditions: Hepatitis B; Hepatitis C

• Registration Number: NCT01772121
• Lead Sponsor: Gilead Sciences

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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Study First Submitted: 2013-01-17
• Study First Submitted QC: 2013-01-18
• Study First Posted: 2013-01-21
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-07
• Last Update Posted: 2015-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Variation in the IL28B rs12979860 SNP	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

Name	Time	Method
Characterize the SNPs present in innate immune factors toll-like receptor 7 (TLR7)	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
Prevelance of HBV and HCV genotypes	One Visit	Assess the prevalence of HBV and HCV genotypes and subtypes in different geographic regions of India

Trial Locations

Locations (19)

Civil Hospital, Dawrpui; 🇮🇳 Aizawl, Mizoram, India

Dharamsi Hospital,Chandni Chowk, South Shivajinagar; 🇮🇳 Sangli, Mahashtra, India

Manipal Hospitals,98, HAL Airport Road; 🇮🇳 Bangalore, Karnataka, India

Global Hospitals, Lakdi ka Pul; 🇮🇳 Hyderabad, Andhra Pradesh, India

Institute of Post Graduate Medical Education And Research,244 A.J.C Bose Road; 🇮🇳 Kolkata, West Bengal,, India

Institute of digestive and liver disease,Ganeshguri; 🇮🇳 Guwahati, Assam, India

Rai Speciality Care Centre, H-6 Janpath,Shyamnagar,Ajmer Road, Sodala; 🇮🇳 Jaipur, Rajasthan, India

Apollo Hospital, Seepat Road; 🇮🇳 Bilaspur, India

Liver Clinic, 203-204, Narmada Complex, Near Kadiwala School, Ring Road; 🇮🇳 Surat, Gujarat, India

Medanta-The Medicity,Sector - 38; 🇮🇳 Gurgaon, Haryana, India

Asian Institute of Gastroenterology , 6-3-661, Somajiguda; 🇮🇳 Hyderabad, Andhra Pradesh, India

Midas Institute of Gastro-enterology, Midas Height,7 - Central Bazar Road,Ramdaspeth; 🇮🇳 Nagpur, Maharashtra, India

Digestive Diseases Centre, Beam Diagnostics Premises, Bajrakabati Road [Mali Sahi], Bata Lane; 🇮🇳 Cuttack, Odhisa, India

Institute of Liver and Biliary Sciences, D-1, Vasant Kunj; 🇮🇳 New Delhi, India

Global Hospitals & Health City,# 439, Cheran Nagar, Perumbakkam, Off OMR, Near Shollinganalur; 🇮🇳 Chennai, Tamil Nadu, India

Diwaliben Mohanlal Mehta Charitable Trust ,1st Foor, Khatau Mansion,95/K Bhulabhai Desai Road; 🇮🇳 Mumbai, Maharashtra, India

Seth GS Medical College and KEM Hospital, Acharya Donde Marg, Parel; 🇮🇳 Mumbai, Maharashtra, India

Dayanand Medical College & Hospital, Tagore Nagar, Civil Lines; 🇮🇳 Ludhiana, Punjab, India

VGM Hospital, 2100, Trichy Road, Rajalakshmi Mills Stop; 🇮🇳 Coimbatore, Tamil Nadu, India