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

Sponsor

Gilead Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT01772121

Collaborator

(none)

1,000

Enrollment

Locations

Duration (Months)

52.6

Patients Per Site

10.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B Hepatitis C

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 Design

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 1, 2012

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

Prevelance of HBV and HCV genotypes [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) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

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