NCT00262288已完成2 期
A Phase II/III Study of the Efficacy and Safety of Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Primary outcomes: Relief of angioedema symptoms
研究概览
简要总结
The purpose of this multi-center study is to explore the efficacy, safety, tolerability and pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor in the treatment of acute attacks in patients with hereditary angioedema.
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
- 16 Years 至 70 Years（Child, 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
Recombinant Human C1INH
Experimental
干预措施: i.v. recombinant human C1 inhibitor (Drug)
结局指标
主要结局
Primary outcomes: Relief of angioedema symptoms
时间窗: 24 hours
次要结局
- Secondary outcomes: Safety and tolerability; pharmacokinetics/pharmacodynamics(90 days)
研究者
研究点 (1)
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