NCT02250560已完成3 期
An Open Study to Investigate the Safety and Efficacy of Replenine®-VF by Continuous Infusion in Haemophilia B Patients Undergoing Major Surgery.
Bio Products Laboratory10 个研究点 分布在 1 个国家开始时间: 2000年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 试验地点
- 10
- 主要终点
- Assessment of control of prevention of bleeding
研究概览
简要总结
The main objective of the study is to investigate the safety and efficacy of Replenine®-VF administered by continuous infusion in appropriate dosage to prevent bleeding and achieve haemostasis in patients with haemophilia B undergoing major surgery.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with moderate to severe Haemophilia B (≤5% baseline Factor IX level) due to undergo major surgery, previously treated patients, at least 16 years of age without inhibitors, currently receiving Factor IX concentrate.
排除标准
- 未提供
研究组 & 干预措施
Replenine®-VF
Experimental
干预措施: Replenine®-VF (High Purity Factor IX) (Biological)
结局指标
主要结局
Assessment of control of prevention of bleeding
时间窗: End of study (Day 5 to Day 10)
Investigator's assessment as excellent, good, moderate or none.
次要结局
未报告次要终点
研究者
研究点 (10)
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