EUCTR2005-001629-27-DE进行中（未招募）不适用
A Long-term Continuation Study of Patients with Infantile-Onset Pompe Disease who were previously enrolled in Protocol AGLU01602
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 17
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) the patient’s legal guardian(s) must provide written informed consent prior to any study-related procedures being performed; (2) the patient and his/her legal guardian(s) must have the ability to comply with the clinical protocol; and (3) the patient must have completed Protocol AGLU01602.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •A patient will be excluded from this study if he/she has experienced any unmanageable AE in Protocol AGLU01602 (as determined and agreed upon by the Principal Investigator and Genzyme Corporation) due to Myozyme that would preclude continuing recombinant human acid a-glucosidase (rhGAA) therapy.
研究者
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