NCT02592057已完成不适用
A Multicenter, Prospective, Observational, Post Marketing Surveillance Study to Evaluate the Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Patients With Chronic Hepatitis C Virus Infection in India
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 532
- 试验地点
- 26
- 主要终点
- Incidence of adverse drug reactions (ADRs) during treatment and up to 4 weeks after discontinuation of a SOF-based regimen
研究概览
简要总结
This study will evaluate the safety and efficacy of sofosbuvir (SOF)-based regimens administered as per the approved prescribing information in adults with chronic hepatitis C virus (HCV) infection treated in routine clinical practice in India.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCV-infected patients living in India
- •Treatment with a SOF-based regimen as determined by the patient's treating physician per the approved prescribing information.
- •Patients who provide written and signed informed consent prior to initiation of treatment where required.
排除标准
- •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 (eg, patients planning to move or leave the country in a foreseeable future)
研究组 & 干预措施
SOF-based regimens
Adults with chronic HCV infection in India who are being treated with a SOF-based treatment regimen as per the approved prescribing information.
干预措施: SOF (Drug)
结局指标
主要结局
Incidence of adverse drug reactions (ADRs) during treatment and up to 4 weeks after discontinuation of a SOF-based regimen
时间窗: Up to Posttreatment Week 4
次要结局
- Proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12)(Posttreatment Week 12)
研究者
研究点 (26)
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