适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 200
研究概览
简要总结
To evaluate long-term safety (primarily by recording adverse events including inhibitors), efficacy and patient acceptance of KOGENATE Bayer in home treatment either on prophylaxis or on demand.
To evaluate both safety and efficacy with respect to lot variability, in particular regarding lot-groups formulated with or without fix between.
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 severe haemophilia A (<2% FVIII baseline plasma levels) treated with KOGENATE Bayer as their only source of recombinant FVIII
排除标准
- •Exclusion criteria must be read in conjunction with the product information (SmPC)
研究组 & 干预措施
Group 1
干预措施: Kogenate (BAY14-2222) (Drug)
研究者
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