NCT02250573已完成3 期
An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery.
Bio Products Laboratory8 个研究点 分布在 3 个国家开始时间: 2005年12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
- 8
- 主要终点
- Incremental recovery for Factor IX
研究概览
简要总结
The main objectives of this study were to investigate the safety and efficacy of Replenine®-VF administered in appropriate dosage by bolus infusion to prevent bleeding and achieve haemostasis in subjects with haemophilia B undergoing surgery.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with moderate to severe haemophilia B undergoing major surgery requiring an in-patient stay of generally 5 to 10 days.
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
Incremental recovery for Factor IX
时间窗: 90 min post-dose
Incremental recovery is defined as peak rise in plasma Factor IX levels divided by Factor IX dose in IU/KG
次要结局
未报告次要终点
研究者
研究点 (8)
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