NCT01810666已完成4 期
Routine Prophylaxis Treatment Versus On-demand Treatment for Children With Severe Hemophilia A: Comparison of All Bleeding Events in Chinese Hemophilia Patients
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Difference of Annualized Number of All Bleeds Between On-demand and Prophylaxis Period
研究概览
简要总结
Comparison of the effect of three times a week prophylaxis on all bleeds with on-demand treatment for children with severe Hemophilia A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, aged 2-16yrs
- •Severe hemophilia A (<1% FVIII:C [Blood Clotting Factor VIII:C] )
- •Minimum of at least 50 documented ED (exposure day) prior to enrolment
- •No measurable inhibitor activity at baseline and history of FVIII inhibitor antibody formation
- •Parents or legal guardians document, sign, and date informed consent
排除标准
- •Another bleeding disease that is different from hemophilia A
- •Known hypersensitivity to the active substance, mouse or hamster protein
- •Thrombocytopenia (platelet count <100 000/mm3) based on previous medical records
结局指标
主要结局
Difference of Annualized Number of All Bleeds Between On-demand and Prophylaxis Period
时间窗: Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment)
Annualized bleedings period 1 minus period 2 ITT analysis set.
次要结局
- Difference of Intra-individual Change of Joint Function During Each Period Assessed by the Hemophilia Joint Health Score Between On-demand and Prophylaxis Period(From baseline to Week 12 (on-demand treatment) and Week 24 (prophylactic treatment))
- Difference of Annualized Number of Joint Bleeds Between On-demand and Prophylaxis Period(Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment))
研究者
研究点 (5)
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