CTRI/2016/08/007167
Active, not recruiting
Phase 4
A Multicenter, Prospective, Observational, Post MarketingSurveillance Study to Evaluate the Safety and Efficacy ofSofosbuvir-based Regimens in Clinical Practice for theTreatment of Patients with Chronic Hepatitis C Virus Infectionin India
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Hepatitis C Positive
- Sponsor
- Gilead Sciences Inc
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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)
Outcomes
Primary Outcomes
Not specified
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