Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS

Bayer0 个研究点目标入组 405 人开始时间: 2008年6月最近更新: 2014年1月29日

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: 405
主要终点: Efficacy and Safety of Kogenate Bayer/FS

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The aim of this international prospective, non-interventional post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer 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 haemophilia A, treated with KOGENATE Bayer/FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE Bayer/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

•Exclusion criteria must be read in conjunction with the local product information.

结局指标

主要结局

Efficacy and Safety of Kogenate Bayer/FS

时间窗: After 12 months, after 24 months

次要结局

未报告次要终点

研究者

发起方

Bayer

申办方类型

Industry

责任方

Sponsor

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