NCT03920540已完成3 期
Phase 3, Double-blind, Randomized, Active-controlled (Part 1) and Open-labeled, Historical Placebo Controlled (Part 2) Study to Evaluate the Efficacy of Hunterase (Idursulfase-beta) in Hunter Syndrome (Mucopolysaccharidosis II) Patients
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in 6-MWT
研究概览
简要总结
The objective of this study is to evaluate the efficacy of GC1111 in Hunter Syndrome Patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Hunter syndrome
- •Male at the age of ≥ 5
- •Adequate abilities (including 6-MWT) to participate in this study in the opinion of the investigator.
- •Voluntarily signed written informed consent to participation in this study
- •Consent to contraception
排除标准
- •Prior treatment with iduronate-2-sulfatase ERT
- •History of bronchotomy, bone marrow trasplanation, or cord blood transplanation.
- •Known hypersensitivity reactions to any of the components of the invetigational product
- •Prior or planned administration of other investigational products within 30 days before treatment with the investigational product in this study or duirng this study.
- •Unable to perform 6-MWT.
结局指标
主要结局
Change in 6-MWT
时间窗: at Week 53 from baseline
次要结局
未报告次要终点
研究者
研究点 (2)
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