NCT02250482已完成3 期
An Open Study to Investigate the Safety and Efficacy of Optivate® in Haemophilia A Patients Undergoing Surgery.
Bio Products Laboratory13 个研究点 分布在 2 个国家开始时间: 2001年11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
- 13
- 主要终点
- Incremental Recovery for plasma Factor VIII
研究概览
简要总结
The main objective of the study is to investigate the safety and efficacy of Optivate®, administered in appropriate dosage to present bleeding and achieve haemostasis in patients with Haemophilia A undergoing surgery.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •Diagnosed with Haemophilia A, at least 12 years of age, due to undergo surgery and have a lifetime exposure of at least 20 exposures to a FVIII concentrate.
排除标准
- 未提供
研究组 & 干预措施
Optivate®
Experimental
Optivate® (Human Coagulation Factor VIII)
干预措施: Optivate® (Human Coagulation Factor VIII) (Biological)
结局指标
主要结局
Incremental Recovery for plasma Factor VIII
时间窗: 90 minutes after pre-operative bolus dose
Incremental recovery is defined as peak rise in plasma Factor VIII levels divided by Factor VIII dose in IU/KG
次要结局
未报告次要终点
研究者
研究点 (13)
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