EUCTR2011-003676-37-ES进行中（未招募）1 期
A Multicenter Extension Study of Taliglucerase alfa in Pediatric Subjects with Gaucher Disease - NA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Successful completion of Protocol PB-06-002 or PB-06-005.
- •2. The subject, parent(s) or legal guardian(s) signs an informed consent and/or assent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects currently taking another investigational drug for any condition.
- •2. The presence of neurological signs and symptoms characteristic of Gaucher disease
- •with complex neuronopathic features other than longstanding oculomotor gaze palsy.
- •3. The presence of a medical, emotional, behavioral or psychological condition that, in
- •the judgment of the Investigator, would interfere with the subject?s compliance with
- •the requirements of the study.
研究者
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