NCT02246868已完成3 期
An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.
Bio Products Laboratory16 个研究点 分布在 2 个国家开始时间: 2001年9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
- 16
- 主要终点
- Incremental Recovery
研究概览
简要总结
The main objectives of this study are to compare the first and second recovery assessments and recovery when a subject changed batch and to assess whether haemostasis was achieved with Optivate® when treating a bleed. The secondary objectives are to evaluate the clinical tolerance and safety of Optivate®.
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
- •Immunocompetent with severe Haemophilia A without inhibitor to FVIII, at least 12 years of age, currently receiving FVIII concentrates and have more than 150 exposures. Subjects who require elective surgergy within 6 months of starting on OPTIVATE® are permitted to be included in this study providing that the surgery could be performed using OPTIVATE® as FVIII cover.
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
时间窗: Comparison of Baseline with 3 months post-baseline
次要结局
未报告次要终点
研究者
研究点 (16)
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