NCT00221195已完成2 期
A Prospective, Randomized, Cross-over Study of an Activated Prothrombin Complex Concentrate for Secondary Prophylaxis in Patients With Hemophilia A and Inhibitors
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Number of Bleeds During 6 Month Treatment Period
研究概览
简要总结
The objective of this study is to assess whether prophylactic therapy with an activated prothrombin complex concentrate (FEIBA)will result in a significant reduction in the number of bleeds in patients with hemophilia and persistent high responding inhibitors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 24 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hemophilia A, any severity, with documented history of high-titer inhibitor (>5BU); current use of bypassing agents (PCCs, aPCCs or rFVIIa) for treatment of bleeds; >/= 6 bleeds requiring bypassing therapy in the previous 6 months
排除标准
- •concomitant immune tolerance therapy; clinically symptomatic liver disease, platelet count less than 100,000
研究组 & 干预措施
On-demand first
Other
Patients receive 6 months of on-demand therapy with study drug followed by 6 months of prophylaxis therapy with study drug
干预措施: activated prothrombin complex concentrate (FEIBA) (Drug)
Prophylaxis first
Other
Patients receive 6 months of prophylaxis therapy with study drug followed by 6 months on-demand therapy with study drug
干预措施: activated prothrombin complex concentrate (FEIBA) (Drug)
结局指标
主要结局
Number of Bleeds During 6 Month Treatment Period
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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