Health Condition 1: B182- Chronic viral hepatitis C
Conditions
Interventions
Intervention1: Sofosbuvir 400 mg & Daclatasvir 60 mg (Fixed dose combination),: Sofosbuvir 400 mg & Daclatasvir 60 mg (Fixed dose combination), treatment duration is 12 weeks
Control Intervention1: N
Sponsors
Mylan Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent 2. Male or female, age equal to or greater than 18 to equal to or less than 65 years 3. Confirmed chronic HCV genotype 3 infection 4. Eligible to receive sofosbuvir/ daclatasvir fixed dose combination in HCV genotype 3
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing female or male with pregnant female partner not willing to use adequate physical barrier. 2. Chronic liver disease of a non-HCV etiology 3. Known coinfection with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV) 4. Documented or suspected Hepatocellular Carcinoma (HCC) 5. Evidence of liver cirrhosis 6. Patients with adequate hemoglobin levels 7. Patients with impaired renal function 8. Patients on Medicinal products which are contraindicated to be used with sofosbuvir/ daclatasvir based combination therapy 9. History of significant pulmonary disease, significant cardiac disease or porphyria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse eventsTimepoint: Treatment period and up to 4 weeks after EOT | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of subjects having the Sustained Virological Response i.e. virological response measured at SVR12 VisitTimepoint: 12 weeks after the End of Treatment | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
JSS Medical Research India Private Limited
Outcome results
None listed