CTRI/2015/04/005672Other3 期
A Phase 4, Prospective, Multinational, Open-label, Non-inferiority Study of Alglucosidase Alfa Manufactured at the 160 L and 4000 L Scales in Treatment Naïve Patients with Infantile-Onset Pompe Disease - PEAS
SanofisynthelaboIndia limited0 个研究点目标入组 24 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •The patient must be less than or equal to 12 months of age; The patient must have documented GAA enzyme deficiency from blood, skin, or muscle tissue; The patient must be naïve to treatment with alglucosidase alfa
- •For complete list of inclusion criteria, please contact the sponsor
排除标准
- •The patient is cross-reactive immunologic material negative; The patient requires invasive ventilator support at the time of enrollment;The patient has decompensated clinical heart failure;
- •For complete list of inclusion criteria, please contact the sponsor
研究者
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