NCT02945228已完成不适用
Drug Use-Results Survey in Patients Infected With Hepatitis C Virus Genotype 2
AbbVie170 个研究点 分布在 1 个国家目标入组 449 人开始时间: 2016年10月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 449
- 试验地点
- 170
- 主要终点
- Percentage of Participants with Sustained Virologic Response (SVR12)
研究概览
简要总结
The main objective of this study is to evaluate the safety and effectiveness of paritaprevir/ritonavir/ombitasvir with ribavirin used for participants infected with chronic hepatitis C virus (HCV) genotype 2 in daily practice in Japan.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCV genotype 2 participants treated with paritaprevir/ritonavir/ombitasvir plus ribavirin in daily practice.
排除标准
- •Participants who have been previously treated with paritaprevir/ritonavir/ombitasvir and ribavirin.
结局指标
主要结局
Percentage of Participants with Sustained Virologic Response (SVR12)
时间窗: 12 weeks after last dose of study drug.
Hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last dose of study drug.
次要结局
- Percentage of Participants with Virologic Failure After Treatment (relapse)(Post-treatment 24 weeks)
- Percentage of Participants with Virologic Failure During Treatment (breakthrough)(Up to 12 Weeks)
- Percentage of Participants with Sustained Virologic Response (SVR24)(24 weeks after the last dose of study drug)
研究者
研究点 (170)
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