Observation of occurrence of Host and Viral Genotypes in Patients withChronic Hepatitis C and Chronic Hepatitis B Infection in India

Not Applicable

Completed

• Conditions: Health Condition 1: null- Hepatitis B & C Virus Infection

• Registration Number: CTRI/2012/08/002936
• Lead Sponsor: Gilead Sciences Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1000

Inclusion Criteria

ï?? Willing and able to provide written informed consent

ï?? Male or female, age >=18 years old

ï?? Willing and able to comply with the visit procedures

ï?? Prior diagnosis of chronic HCV infection or chronic HBV infection; a history of chronic HCV or HBV infection provided by a subject or a subjectâ??s health provider is sufficient; documentation not required At each center, no more than 40% of the patients with previously known chronic HBV enrolled in the study may be inactive carriers (i.e., HBsAg positive with HBV DNA < 2000 IU/ml).

Exclusion Criteria

ï?? History of difficulty with blood collection and/or poor

venous access for the purposes of phlebotomy.

ï?? History of bleeding disorder

ï?? Blood loss requiring transfusion or 3 g/dL decrease in

hemoglobin within 4 days of the visit

ï?? Knowingly co-infected with HCV/HBV or with HIV

ï?? Currently undergoing therapy for chronic hepatitis C or chronic hepatitis B. For the purposes of the study, the last dose of prior HCV or HBV therapy (if applicable) must have been administered 30 days prior to the study visit date for this trial.

ï?? Currently receiving treatment with any other investigational agent or device. For the purposes of the study, the last dose of any investigational agent or utilization of any investigational device must have been administered 30 days prior to the study visit date for this trial.

ï?? Enrolled in another clinical study evaluating a treatment or procedure. Subjects may be enrolled in another clinical study evaluating a treatment or procedure >=24 hours following the completion of the study visit assessments and procedures for this trial.

Study & Design

• Study Type: Observational
• Study Design: Not specified