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

Purpose

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
Hepatitis B Hepatitis C


Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B Hepatitis C

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

Variation in the IL28B rs12979860 SNP [ Time Frame: One Visit ] [ Designated as safety issue: No ]
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 [ Time Frame: One Visit ] [ Designated as safety issue: No ]
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) [ Time Frame: One Visit ] [ Designated as safety issue: No ]
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

Biospecimen Retention: Samples With DNA

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


Enrollment:	1000
Study Start Date:	May 2012
Study Completion Date:	October 2012
Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
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

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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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

Criteria

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772121

Locations


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

Sponsors and Collaborators

Gilead Sciences

More Information


Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT01772121 History of Changes
Other Study ID Numbers:	GX-US-174-0196
Study First Received:	January 17, 2013
Last Updated:	July 7, 2015
Health Authority:	India: Drugs Controller General of India

Keywords provided by Gilead Sciences:


HBV, HCV, chronic, India, observational study, prevalence, genotypes, SNPs, viral hepatitis

Additional relevant MeSH terms:


Hepatitis C Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis B Hepatitis B, Chronic Hepatitis, Viral, Human Virus Diseases	Flaviviridae Infections RNA Virus Infections Liver Diseases Digestive System Diseases Enterovirus Infections Picornaviridae Infections Hepadnaviridae Infections DNA Virus Infections

ClinicalTrials.gov processed this record on September 26, 2016