NCT00214734已完成不适用
Evaluation of Safety, Efficacy, and Immunogenicity of ADVATE in Hemophilia A- An ADVATE Post-authorization Safety Surveillance (PASS) Study
Baxalta now part of Shire37 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2004年10月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 37
研究概览
简要总结
The primary objective of this post-authorization safety surveillance is to measure the incidence of adverse events that are at least possibly related to ADVATE use, in subjects receiving ADVATE in routine clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject has moderate or severe hemophilia A (baseline FVIII less than or equal to 5%)
- •Subject currently has no measurable FVIII inhibitor titer greater than or equal to 1 BU (Bethesda or Nijmegen method)
- •Subject has been prescribed ADVATE by their treating physician
- •Subject may be of any age
- •Subject or parent/legally authorized representative has provided written informed consent
排除标准
- 未提供
研究者
研究点 (37)
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