NCT03201718已完成不适用
Post-marketing Surveillance Study of Viekira/ Exviera Tablets for Korean Hepatitis C Patients According to the Standard for "Re-examination of New Drugs"
AbbVie59 个研究点 分布在 1 个国家目标入组 505 人开始时间: 2017年8月17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
- 505
- 试验地点
- 59
- 主要终点
- Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
研究概览
简要总结
Post-marketing surveillance study to evaluate the real world safety and effectiveness of Viekira/ Exviera (paritaprevir/ritonavir/ombitasvir and dasabuvir) administered under a normal, routine treatment practice by Korean patients with Hepatitis C.
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
- •Participants with type C hepatitis
- •Participants prescribed Viekira/Exviera in accordance with approved local label
排除标准
- 未提供
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 the last dose of study drug
the lower limit of quantitation (LLOQ) SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level 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 Post-treatment Relapse(From the end of treatment through 12 weeks after the last dose of study drug)
- Percentage of Participants With On-treatment Virologic Failure(Up to 24 weeks)
研究者
研究点 (59)
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