NCT01562158已完成2 期
A Multi-centre, Randomised, Double-blind, Parallel Groups, Placebocontrolled Trial on Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Treatment of Bleeding in Patients Following Stem Cell Transplantation (SCT)
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
- 100
- 试验地点
- 1
- 主要终点
- Effect on bleeding, defined as change in bleeding score
研究概览
简要总结
This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the efficacy of placebo and activated recombinant human factor VII in patients having undergone allogeneic or autologous stem cell transplantation.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have undergone allogeneic or autologous stem cell transplantation
排除标准
- •Known or suspected allergy to trial product
- •Participation in other trials with unapproved drugs or trials with equal or similar objective
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: standard therapy (Procedure)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
Low dose
Experimental
干预措施: standard therapy (Procedure)
Low dose
Experimental
干预措施: activated recombinant human factor VII (Drug)
Medium dose
Experimental
干预措施: standard therapy (Procedure)
Medium dose
Experimental
干预措施: activated recombinant human factor VII (Drug)
High dose
Experimental
干预措施: standard therapy (Procedure)
High dose
Experimental
干预措施: activated recombinant human factor VII (Drug)
结局指标
主要结局
Effect on bleeding, defined as change in bleeding score
次要结局
- Bleeding evaluation
- Adverse events
- Transfusion requirements
研究者
研究点 (1)
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