NL-OMON55395已完成2 期
An open-label, multicenter, multinational extension study of the long-term safety and pharmacokinetics of repeated biweekly infusions of neoGAA in patients with Pompe disease - NEO1 extensie
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients with Pompe disease who previously completed a neoGAA study.
排除标准
- •* The patient is concurrently participating in another clinical study using
- •investigational treatment.
- •* The patient, in the opinion of the Investigator, is unable to adhere to the
- •requirements of the study.
- •* The patient has clinically significant organic disease (with the exception of
- •symptoms relating to Pompe disease), including clinically significant
- •cardiovascular, hepatic, pulmonary, neurologic, or renal disease, or other
- •medical condition, serious intercurrent illness, or extenuating circumstance
- •that, in the opinion of the Investigator, precludes participation in the study
- •or potentially decreases survival.
研究者
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