NCT03341871已完成不适用
Glecaprevir/Pibrentasvir Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1-6
AbbVie1 个研究点 分布在 1 个国家目标入组 1,095 人开始时间: 2017年12月27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
- 1,095
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
研究概览
简要总结
This multi-center, post-marketing, observational study evaluates the real world safety and effectiveness of glecaprevir plus pibrentasvir use in participants infected with the hepatitis C virus genotype 1 - 6.
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
- 0 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic hepatitis C virus infection and administering glecaprevir plus pibrentasvir.
排除标准
- •Patients previously treated with glecaprevir plus pibrentasvir.
结局指标
主要结局
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
时间窗: 12 weeks after last dose of drug
SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level \< the lower limit of quantification (LLOQ) 12 weeks after the last dose of Glecaprevir plus Pibrentasvir.
次要结局
- Percentage of Participants with Post-treatment Relapse(Up to 24 weeks after last dose of drug)
- Percentage of Participants with On-treatment Virologic Failure(Up to 12 weeks after first dose)
- Percentage of Participants Achieving SVR24(24 weeks after last dose of drug)
- Percentage of Participants Achieving SVR8(8 weeks after last dose of drug)
- Percentage of Participants Achieving SVR4(4 weeks after last dose)
研究者
研究点 (1)
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