NCT01561391已完成4 期
An Open-Label, Randomized, Parallel, Multicenter Trial Comparing the Safety and Efficacy of rFVIIa When Administered as i.v. Bolus or i.v. Continuous Infusion to Hemophiliacs With Inhibitors During and After Major Surgery
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Presence and maintenance of haemostasis
研究概览
简要总结
This trial is conducted in North America. The aim of this trial is to compare the safety and efficacy of activated recombinant human factor VII in patients with haemophilia A or B undergoing major surgical procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have haemophilia A or B with inhibitors to factor VIII or IX, respectively
- •Have had a historical inhibitor level of at least five Bethesda units or have had an inadequate haemostatic response to 250 U/kg of factor VIII or IX or have had an inadequate response to FEIBA
- •Require pre-planned major surgery in hospital
排除标准
- •Have participated in or have been treated with any investigational drug other than activated recombinant human factor VII within the last thirty days
- •Have been treated with any haemostatic agent, including rFVIIa, within 48 hours of preoperative dose
- •Have any haemostatic disorder other than haemophilia
研究组 & 干预措施
Continuous infusion
Experimental
干预措施: activated recombinant human factor VII (Drug)
Bolus injection
Experimental
干预措施: activated recombinant human factor VII (Drug)
Control
Experimental
干预措施: factor IX (Other)
Control
Experimental
干预措施: factor VIII (Drug)
结局指标
主要结局
Presence and maintenance of haemostasis
Changes in FVII:C (Factor VII clotting activity) levels following administration of activated recombinant human factor VII
次要结局
- Changes in coagulation-related parameters
- Adverse Events
研究者
研究点 (1)
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