NCT00108797已完成4 期
NovoSeven® (rFVIIa) by Single Dose for Home Treatment of Joint Bleeds in Haemophilia Patients With Inhibitors: A Pilot, Double-Blind Study Versus Standard Multiple Doses of NovoSeven® and Open-Label FEIBA®
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 21
- 主要终点
- Comparison with FEIBA on review of pain, joint mobility and circumference
研究概览
简要总结
This trial is conducted in the United States of America (USA). This study compares the effectiveness and safety of NovoSeven® to FEIBA (FEIBA VH) in haemophilia patients with inhibitors being treated for joint bleeds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 20 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of hemophilia A or B with inhibitors to factor VIII or IX, respectively
排除标准
- 未提供
结局指标
主要结局
Comparison with FEIBA on review of pain, joint mobility and circumference
时间窗: after 1, 3, 6, and 9 hours of treatment, respectively
次要结局
- Safety variables
研究者
研究点 (21)
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