A Prospective Observational Post-Marketing Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 554
- 主要终点
- Incidence of adverse drug reaction (ADR) under real world settings
研究概览
简要总结
This use-results post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF) administered in combination with Rebetol® capsules (ribavirin, REB) will evaluate the safety and efficacy of SOF administered in combination with ribavirin under real world use in Japan. Among adult patients with chronic genotype 2 hepatitis C virus (HCV) infection and treated with SOF+ribavirin in routine clinical use, the primary objective of this study is to evaluate the incidence of adverse drug reactions (ADRs) under real world settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 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
- •Adult patients with serogroup 2 (genotype 2) chronic HCV infection with or without compensated cirrhosis
- •Patients who are prescribed SOF+REB
排除标准
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
SOF+REB
Adult patients with genotype 2 chronic HCV infection with or without compensated cirrhosis who take SOF+REB as part of routine clinical care at a participating clinical site.
干预措施: SOF (Drug)
SOF+REB
Adult patients with genotype 2 chronic HCV infection with or without compensated cirrhosis who take SOF+REB as part of routine clinical care at a participating clinical site.
干预措施: REB (Drug)
结局指标
主要结局
Incidence of adverse drug reaction (ADR) under real world settings
时间窗: Up to 16 weeks
次要结局
- Proportion of participants with sustained virologic response (SVR) 12 and 24 weeks after discontinuation of therapy (SVR12 and SVR24)(Posttreatment Weeks 12 and 24)
- Proportion of participants with HCV NS5B resistance associated variants among patients who do not achieve SVR at 12 weeks(Approximately 12 weeks after treatment completion or discontinuation)