NCT00266006已完成2 期
Safety of Eptacog Alfa (Activated) (Genetical Recombination) on Adverse Events and Serious Adverse Events in Patients With Acute Intracerebral Haemorrhage.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- The Occurrence of thromboembolic serious adverse event
研究概览
简要总结
This trial is conducted in Japan. The purpose of this trial is to evaluate the safety and preliminary efficacy of Activated Recombinant Factor VII (NN-007) in patients with acute intracerebral haemorrhage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Spontaneous ICH
排除标准
- •Time of ICH onset > 3 hours
- •Patients with secondary ICH
- •Pre-existing disability
- •Hemophilia
结局指标
主要结局
The Occurrence of thromboembolic serious adverse event
时间窗: Until 90 days
次要结局
- Reducing disability and improving clinical outcome
- Reducing haematoma growth
研究者
研究点 (2)
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