Health Condition 1: null- Hepatitis C Positive
Conditions
Interventions
Intervention1: Savaldi: Sofosbuvir 400mg film coated tablets OD for 12 or 24 weeks
Sponsors
Gilead Sciences Inc
KlinEra Corporation India
Eligibility
Inclusion criteria
Inclusion criteria: • Age greater than 18 years • HCV-infected patients living in India Treatment with a Sovaldi®-based regimen, as determined by the patientâ??s treating physician per the approved prescribing information • When required by the investigatorâ??s site, provision of written and signed informed consent prior to initiation of treatment
Exclusion criteria
Exclusion criteria: • Concurrent participation in an HCV clinical trial (except trials not testing investigational medicinal products) • Patients presenting a risk of not being able to be followed (e.g.patients planning to move or leave the country in the foreseeable future)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TADRs (both serious and non-serious) reported during the treatment period and up to 4 weeks after discontinuation of a SOF-based regimen in adult subjects in India (primary endpoint)Timepoint: ADRs (both serious and non-serious) reported during the treatment period and up to 4 weeks after discontinuation of a SOF-based regimen in adult subjects in India | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with SVR at 12 weeks post treatment, as determined from available HCV RNA quantitation data collected 12 or more weeks after treatmentTimepoint: Proportion of patients with SVR at 12 weeks post treatment, as determined from available HCV RNA quantitation data collected 12 or more weeks after treatment | — |
Countries
India
Contacts
Public ContactRajeev Singh
Klinera Corporation India
Outcome results
None listed