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

Gilead Sciences

Status: Completed

Conditions: Hepatitis C; Hepatitis B

Study type: Observational

Funder types: Industry

Identifiers

NCT01772121

GX-US-174-0196

Details and patient eligibility

About

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

Full 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

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

1,000 participants in 2 patient groups

HCV Cohort

Description:

A total of 1000 subjects were enrolled in the study and of that 500 subjects had a diagnosis of chronic HCV infection

HBV Cohort

Description:

A total of 1000 subjects were enrolled in the study and of that 500 subjects had a diagnosis of chronic HBV infection