NCT01205243已完成不适用
An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Efficacy of ZIAGEN® Administered in Korean Patients According to the Prescribing Information
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 671
- 试验地点
- 1
- 主要终点
- Occurrence of adverse event after ZIAGEN® administration
研究概览
简要总结
An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and efficacy of ZIAGEN® administered in Korean patients according to the prescribing information.
详细描述
This study will collect clinical data, mainly focused on safety, in Korean population as per the requirement of KFDA for market authorization.
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ZIAGEN®
Patients administrated ZIAGEN® at the site
干预措施: ZIAGEN® (Drug)
结局指标
主要结局
Occurrence of adverse event after ZIAGEN® administration
时间窗: 12month
次要结局
- Occurrence of unexpected adverse drug reaction after ZIAGEN® administration(12 month)
- Occurrence of serious adverse event after ZIAGEN® administration(12month)
- efficacy after ZIAGEN® administration(12month)
研究者
研究点 (1)
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