This is an Observational Study of the medicine already available in the Market to check the Safety and Effectiveness of Sofosbuvir-based treatment in clinical Practice for the Patients with Chronic Hepatitis C Virus Infection in India
Phase 4
- Conditions
- Health Condition 1: null- Hepatitis C Positive
- Registration Number
- CTRI/2016/08/007167
- Lead Sponsor
- Gilead Sciences Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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
• 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)
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TADRs (both serious and non-serious) reported during the treatment period and up to 4 weeks <br/ ><br>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 <br/ ><br>after discontinuation of a SOF-based regimen in adult subjects in India
- Secondary Outcome Measures
Name Time Method Proportion of patients with SVR at 12 weeks post treatment, as determined from available <br/ ><br>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 <br/ ><br>HCV RNA quantitation data collected 12 or more weeks after treatment