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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01772121
• Other study ID #: GX-US-174-0196
• Status: Completed
• Phase: N/A
• First received: January 17, 2013
• Last updated: July 7, 2015
• Start date: May 2012
• Est. completion date: October 2012

Study information

• Verified date: July 2015
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis C
• Hepatitis, Chronic

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation in the IL28B rs12979860 SNP	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	No
Secondary	Prevelance of HBV and HCV genotypes	Assess the prevalence of HBV and HCV genotypes and subtypes in different geographic regions of India	One Visit	No
Secondary	Characterize the SNPs present in innate immune factors toll-like receptor 7 (TLR7)	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	No