NCT03500562终止不适用
Daclatasvir-Based Therapy Safety Surveillance in Chinese Patients With Chronic Hepatitis C
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2018年5月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of adverse events (AEs)
研究概览
简要总结
Study is a non-interventional, prospective, multicenter post marketing surveillance study to determine the safety of daclatasvir based therapy
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
- •Participants 18 years of age and older
- •Participants with Chronic Hepatitis C virus (CHC) who are eligible for treatment with branded DCV-based therapy as indicated in the locally approved label
排除标准
- •Participants under the age of 18
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Number of adverse events (AEs)
时间窗: Approximately 72 weeks
Number of serious adverse events (SAEs)
时间窗: Approximately 72 weeks
次要结局
- Number of participants who discontinue therapy due to an AE(Approximately 72 weeks)
- Effectiveness of daclatasvir DCV-based therapy(Approximately 72 weeks)
研究者
研究点 (1)
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