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

July 7, 2015 updated by: Gilead Sciences

Prevalence of Host and Viral Genotypes in Patients With Chronic Hepatitis B and Hepatitis C Infection in India

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Bilaspur, India, 495006
        • Apollo Hospital, Seepat Road
      • New Delhi, India, 110070
        • Institute of Liver and Biliary Sciences, D-1, Vasant Kunj
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500004
        • Global Hospitals, Lakdi ka Pul
      • Hyderabad, Andhra Pradesh, India, 500082
        • Asian Institute of Gastroenterology , 6-3-661, Somajiguda
    • Assam
      • Guwahati, Assam, India, 781 006
        • Institute of digestive and liver disease,Ganeshguri
    • Gujarat
      • Surat, Gujarat, India, 395002
        • Liver Clinic, 203-204, Narmada Complex, Near Kadiwala School, Ring Road
    • Haryana
      • Gurgaon, Haryana, India, 122001
        • Medanta-The Medicity,Sector - 38
    • Karnataka
      • Bangalore, Karnataka, India, 560017
        • Manipal Hospitals,98, HAL Airport Road
    • Maharashtra
      • Mumbai, Maharashtra, India, 400 036
        • Diwaliben Mohanlal Mehta Charitable Trust ,1st Foor, Khatau Mansion,95/K Bhulabhai Desai Road
      • Mumbai, Maharashtra, India, 400012
        • Seth GS Medical College and KEM Hospital, Acharya Donde Marg, Parel
      • Nagpur, Maharashtra, India, 440010
        • Midas Institute of Gastro-enterology, Midas Height,7 - Central Bazar Road,Ramdaspeth
    • Mahashtra
      • Sangli, Mahashtra, India, 416 416
        • Dharamsi Hospital,Chandni Chowk, South Shivajinagar
    • Mizoram
      • Aizawl, Mizoram, India
        • Civil Hospital, Dawrpui
    • Odhisa
      • Cuttack, Odhisa, India, 753001
        • Digestive Diseases Centre, Beam Diagnostics Premises, Bajrakabati Road [Mali Sahi], Bata Lane
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Dayanand Medical College & Hospital, Tagore Nagar, Civil Lines
    • Rajasthan
      • Jaipur, Rajasthan, India, 342019
        • Rai Speciality Care Centre, H-6 Janpath,Shyamnagar,Ajmer Road, Sodala
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600 100
        • Global Hospitals & Health City,# 439, Cheran Nagar, Perumbakkam, Off OMR, Near Shollinganalur
      • Coimbatore, Tamil Nadu, India, 641005
        • VGM Hospital, 2100, Trichy Road, Rajalakshmi Mills Stop
    • West Bengal,
      • Kolkata, West Bengal,, India, 700020
        • Institute of Post Graduate Medical Education And Research,244 A.J.C Bose Road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One Visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One Visit
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
One Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

January 17, 2013

First Submitted That Met QC Criteria

January 18, 2013

First Posted (Estimate)

January 21, 2013

Study Record Updates

Last Update Posted (Estimate)

July 9, 2015

Last Update Submitted That Met QC Criteria

July 7, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GX-US-174-0196

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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