NCT00969319已完成不适用
Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 105
- 主要终点
- Kind of bleedings
研究概览
简要总结
The aim of this international prospective post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer/FS in treatment of patients with haemophilia A under daily-life treatment conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosis of hemophilia A, independent of age, treated with KOGENATE® FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE® FS. For pretreated patients with more than 100 exposure days an inhibitor assessment within three months prior to enrollment should be available; for pretreated patients with less than 100 exposure days an inhibitor assessment at baseline should be available.
排除标准
- 未提供
结局指标
主要结局
Kind of bleedings
时间窗: After 12 months and after 24 months
Continuation of therapy
时间窗: After 12 months and after 24 months
Overall assessment by the physician
时间窗: After 12 months and after 24 months
Total consumption of FVIII
时间窗: After 12 months and after 24 months
Number of bleedings
时间窗: After 12 months and after 24 months
次要结局
- Adverse event collection(After 12 months and after 24 months)
研究者
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