CTRI/2011/11/002135Other4 期
A post authorization Safety and Effectiveness study of RECOMBINATE in India
Baxter India Pvt Ltd0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- Other
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1.Subjects who have clinically proven hemophiliaA
- •2.Subjects have been prescribed RECOMBINATE by their treating physician at their discretion
- •3.Subject may be of any age and the upper limit of age is 99.
- •4.Subject or parent/legally authorized representative has provided written informed consent
排除标准
- •1.Subject has known intolerance or allergic reaction to any of the constituents in the formulation of RECOMBINATE
- •2.Patients who have known hypersensitivity to Factor VIII concentrates or to any of the excipients or trace impurities; known hypersensitivity to bovine, murine, or hamster protein
- •3.Patients with severe cardiac diseases, including myocardial infarction, cardiac insufficiency class III or higher, etc.
- •4.Other diseases with clinical significance: alcohol abuse, drug abuse, emotional disturbance, and dysgnosia
研究者
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