NCT00189982已完成2 期
Recombinant Antihemophilic Factor Manufactured and Formulated Without Added Human or Animal Proteins (ADVATE rAHF-PFM): Safety Monitoring in Pediatric Patients Diagnosed With Severe to Moderately Severe Hemophilia A - A Continuation of Baxter Clinical Study 060101
Baxalta now part of Shire2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2004年12月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Assessment of safety, as measured by the incidence, causality, and severity of adverse experiences
研究概览
简要总结
The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the treatment of children with hemophilia A. The study is open to pediatric patients in Canada who completed Baxter Study 060101.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 6 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject must have participated and completed participation in Baxter's clinical study 060101
- •Subject or parent/legally authorized representative has provided written informed consent
排除标准
- •Subjects who have withdrawn from Baxter's Clinical Study 060101 prior to the termination of the study
结局指标
主要结局
Assessment of safety, as measured by the incidence, causality, and severity of adverse experiences
时间窗: Throughout the study period of approximately 23 months.
次要结局
- Assessment of the hemostatic efficacy in the treatment of bleeding episodes;(At least 50 exposure days or a total treatment time of 6 months, whichever came first.)
- assessment of the hemostatic efficacy in surgical or invasive procedures(From day of surgery until time of discharge from hospital or clinic (up to approximately 2 weeks post surgery).)
研究者
研究点 (2)
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