Clinical trial NCT01772121: Observational Study on Prevalence of Host and Viral Genotypes in Chronic Hepatitis B and Hepatitis C Patients in India
Official title: Prevalence of Host and Viral Genotypes in Patients With Chronic Hepatitis B and Hepatitis C Infection in India
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B
Hepatitis C
Keywords: HBV, HCV, chronic, India, observational study, prevalence,
genotypes, SNPs, viral hepatitis
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-01-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Eligibility 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

Primary outcomes:
measure: Variation in the IL28B rs12979860 SNP
timeFrame: One Visit
Secondary outcomes:
measure: Prevelance of HBV and HCV genotypes
timeFrame: One Visit
measure: Characterize the SNPs present in innate immune factors toll-like receptor 7 (TLR7)
timeFrame: One Visit
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Global Hospitals, Lakdi ka Pul
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology , 6-3-661, Somajiguda
state: Andhra Pradesh
city: Guwahati
country: India
facility: Institute of digestive and liver disease,Ganeshguri
state: Assam
city: Surat
country: India
facility: Liver Clinic, 203-204, Narmada Complex, Near Kadiwala School, Ring Road
state: Gujarat
city: Gurgaon
country: India
facility: Medanta-The Medicity,Sector - 38
state: Haryana
city: Bangalore
country: India
facility: Manipal Hospitals,98, HAL Airport Road
state: Karnataka
city: Mumbai
country: India
facility: Diwaliben Mohanlal Mehta Charitable Trust ,1st Foor, Khatau Mansion,95/K Bhulabhai Desai Road
state: Maharashtra
city: Mumbai
country: India
facility: Seth GS Medical College and KEM Hospital, Acharya Donde Marg, Parel
state: Maharashtra
city: Nagpur
country: India
facility: Midas Institute of Gastro-enterology, Midas Height,7 - Central Bazar Road,Ramdaspeth
state: Maharashtra
city: Sangli
country: India
facility: Dharamsi Hospital,Chandni Chowk, South Shivajinagar
state: Mahashtra
city: Aizawl
country: India
facility: Civil Hospital, Dawrpui
state: Mizoram
city: Cuttack
country: India
facility: Digestive Diseases Centre, Beam Diagnostics Premises, Bajrakabati Road [Mali Sahi], Bata Lane
state: Odhisa
city: Ludhiana
country: India
facility: Dayanand Medical College & Hospital, Tagore Nagar, Civil Lines
state: Punjab
city: Jaipur
country: India
facility: Rai Speciality Care Centre, H-6 Janpath,Shyamnagar,Ajmer Road, Sodala
state: Rajasthan
city: Chennai
country: India
facility: Global Hospitals & Health City,# 439, Cheran Nagar, Perumbakkam, Off OMR, Near Shollinganalur
state: Tamil Nadu
city: Coimbatore
country: India
facility: VGM Hospital, 2100, Trichy Road, Rajalakshmi Mills Stop
state: Tamil Nadu
city: Kolkata
country: India
facility: Institute of Post Graduate Medical Education And Research,244 A.J.C Bose Road
state: West Bengal,
city: Bilaspur
country: India
facility: Apollo Hospital, Seepat Road
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences, D-1, Vasant Kunj
Study officials:
References: