NCT03205618已完成不适用
Effectiveness of Daclatasvir-Containing Regimens in Patients Treated in Real-Life Setting in Kingdom of Saudi Arabia (KSA), United Arab Emirates (UAE) and Qatar
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2016年4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
- 182
- 试验地点
- 1
- 主要终点
- Number of participants achieving sustained virological response 12 weeks post-treatment (SVR12)
研究概览
简要总结
The study will provide safety and efficacy information among patients receiving daclatasvir. It will describe daclatasvir prescribing patterns and provide a clinical profile of patients receiving the treatment in KSA, UAE, and Qatar.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adult patients greater than or equal to 18 years of age
- •Diagnosed with chronic hepatitis C
- •Ended treatment with daclatasvir-containing regimen no later than 01-Oct-2015
排除标准
- •Use of a daclatasvir-containing regimen in a clinical trial setting
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Number of participants achieving sustained virological response 12 weeks post-treatment (SVR12)
时间窗: 12 weeks after the last dose of study treatment
Patients will be considered to have achieved SVR12 if they have a documented undetectable viral load on or after Week 12 following the end of treatment.
次要结局
- Incidence of Adverse Events leading to discontinuation(Up to 12 months)
- Distribution of SVR12 by previous liver transplantation(12 weeks after the last dose of study treatment)
- Incidence of Serious Adverse Events (SAE)(Up to 12 months)
- Distribution of SVR12 by Treatment Regimen(12 weeks after the last dose of study treatment)
- Distribution of SVR12 by HIV co-infection(12 weeks after the last dose of study treatment)
- Distribution of SVR12 by Genotype(12 weeks after the last dose of study treatment)
- Distribution of SVR12 by HCV-Treatment Experience(12 weeks after the last dose of study treatment)
- Distribution of SVR12 by Country(12 weeks after the last dose of study treatment)
研究者
研究点 (1)
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