NCT02246894已完成3 期
An Open Multicentre Phase III Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Severe Haemophilia A.
Bio Products Laboratory5 个研究点 分布在 1 个国家开始时间: 2003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
- 5
- 主要终点
- Consumption of FVIII
研究概览
简要总结
The main objectives of this study are:
- to assess Optivate® consumption (IU/kg consumed per month for prophylactic and on-demand therapy and dose at each bleed).
- to assess clinical outcome when treating a bleed with Optivate®.
- to evaluate Optivate® in terms of clinical tolerance and safety in children under the age of 6 years. .
- to assess FVIII inhibitor development during the study.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- — 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children under the age of 6 years with a diagnosis of severe Haemophilia A. Subjects who required FVIII therapy and did not demonstrate inhibitors to FVIII.
- •Children with history of inhibitors to FVIII or clinically significant renal or liver disease were not eligible to participate in the study.
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
Consumption of FVIII
时间窗: Day 0 to Week 26
次要结局
未报告次要终点
研究者
研究点 (5)
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