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

NCT ID: NCT01772121

Last Updated: 2015-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-10-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Hepatitis B Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

HBV Cohort

A total of 1000 subjects were enrolled in the study and of that 500 subjects had a diagnosis of chronic HBV infection

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Global Hospitals, Lakdi ka Pul

Hyderabad, Andhra Pradesh, India

Site Status

Asian Institute of Gastroenterology , 6-3-661, Somajiguda

Hyderabad, Andhra Pradesh, India

Site Status

Institute of digestive and liver disease,Ganeshguri

Guwahati, Assam, India

Site Status

Liver Clinic, 203-204, Narmada Complex, Near Kadiwala School, Ring Road

Surat, Gujarat, India

Site Status

Medanta-The Medicity,Sector - 38

Gurgaon, Haryana, India

Site Status

Manipal Hospitals,98, HAL Airport Road

Bangalore, Karnataka, India

Site Status

Diwaliben Mohanlal Mehta Charitable Trust ,1st Foor, Khatau Mansion,95/K Bhulabhai Desai Road

Mumbai, Maharashtra, India

Site Status

Seth GS Medical College and KEM Hospital, Acharya Donde Marg, Parel

Mumbai, Maharashtra, India

Site Status

Midas Institute of Gastro-enterology, Midas Height,7 - Central Bazar Road,Ramdaspeth

Nagpur, Maharashtra, India

Site Status

Dharamsi Hospital,Chandni Chowk, South Shivajinagar

Sangli, Mahashtra, India

Site Status

Civil Hospital, Dawrpui

Aizawl, Mizoram, India

Site Status

Institute of Liver and Biliary Sciences, D-1, Vasant Kunj

New Delhi, New Delhi, India

Site Status

Digestive Diseases Centre, Beam Diagnostics Premises, Bajrakabati Road [Mali Sahi], Bata Lane

Cuttack, Odhisa, India

Site Status

Dayanand Medical College & Hospital, Tagore Nagar, Civil Lines

Ludhiana, Punjab, India

Site Status

Rai Speciality Care Centre, H-6 Janpath,Shyamnagar,Ajmer Road, Sodala

Jaipur, Rajasthan, India

Site Status

Global Hospitals & Health City,# 439, Cheran Nagar, Perumbakkam, Off OMR, Near Shollinganalur

Chennai, Tamil Nadu, India

Site Status

VGM Hospital, 2100, Trichy Road, Rajalakshmi Mills Stop

Coimbatore, Tamil Nadu, India

Site Status

Institute of Post Graduate Medical Education And Research,244 A.J.C Bose Road

Kolkata, West Bengal, India

Site Status

Apollo Hospital, Seepat Road

Bilāspur, , India

Site Status

Countries

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India

Other Identifiers

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GX-US-174-0196

Identifier Type: -

Identifier Source: org_study_id

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