Health Condition 1: null- Hepatitis B & C Virus Infection
Conditions
Interventions
None listed
Sponsors
Gilead Sciences Inc
Eligibility
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To 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. Timepoint: This is a singal visit study. Primary out come result is depend on blood investigation. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the prevalence of HBV and HCV genotypes and subtypes in the different geographic regions of India.. ï??To characterize the prevalence of ITPA SNPs rs1127354 and rs7270101 in patients with chronic hepatitis C in the different geographic regions of India. ï?? ï??To characterize subject awareness of viral hepatitis, treatment options and access to care in different geographic regions of India. Timepoint: After First Visit | — |
Countries
India
Contacts
Public ContactDr Rohit Shete
Klinera Corporation India
Outcome results
None listed