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
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 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.
研究组 & 干预措施
Comparator (Part 1)
Active Comparator
In Part 1, all participants who randomized into comparator arm should receive the GC1111 for 52 weeks.
干预措施: Comparator (Combination Product)
GC1111
Experimental
In part 1, all participants who randomized into GC1111 arm should receive the GC1111 for 52 weeks.
In part 2, all enrolled participants should receive the GC1111 for 52 weeks.
干预措施: GC1111 (Combination Product)
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 (1)
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Unknown
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