跳至主要内容
临床试验/NCT03500562
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

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

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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