NCT02831660已完成3 期
A Compassionate Use Program of Idarucizumab for Reversal of the Anticoagulant Effects of Dabigatran in Japanese Patients Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Percentage of Subjects With Drug-related Adverse Events
研究概览
简要总结
The objective is to collect the safety data of idarucizumab for patients treated with dabigatran who require rapid reversal of the anticoagulant effects of dabigatran in cases of uncontrolled or life-threatening bleeding or when emergency surgery or urgent procedures are required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 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
idarucizumab
Experimental
干预措施: idarucizumab (Drug)
结局指标
主要结局
Percentage of Subjects With Drug-related Adverse Events
时间窗: from first drug administration until 5 days after last drug administration, up to 6 days.
Percentage of subjects with drug-related adverse events is presented
次要结局
未报告次要终点
研究者
研究点 (1)
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