NCT01301898已完成1 期
Randomized, Single-blind, Active-controlled, Phase 1/2 Study to Evaluate the Safety and Efficacy of GC1111 (Recombinant Human Iduronate-2-sulfatase) in Hunter Syndrome (Mucopolysaccharidosis II) Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Primary Outcome
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of GC1111 (recombinant human iduronate-w-sulfatase) in Hunter Syndrome (Mucopolysaccharidosis II) 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
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 35 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosis of MPS II based on both clinical and biochemical criteria
- •Male, ages 6 to 35 years old
- •Patients who are able to comply with the study requirements
- •Patients who have given voluntary written consent to participate in the study
- •Patients who is acceptable for using an appropriate method of contraception
排除标准
- •History of a tracheostomy or a bone marrow transplant
- •Known hypersensitivity to idursulfase
- •Known shock to idursulfase
- •History of receiving treatment with another investigational therapy within the past 30 days
- •History of a stem cell transplant
- •Known hypersensitivity to any of the components of idursulfase
研究组 & 干预措施
GC1111_0.5mg/kg
Experimental
干预措施: GC1111_0.5mg/kg (Drug)
GC1111_1.0mg/kg
Experimental
干预措施: GC1111_1.0mg/kg (Drug)
Elaprase_0.5mg/kg
Active Comparator
干预措施: Elaprase_0.5mg/kg (Drug)
结局指标
主要结局
Primary Outcome
时间窗: baseline, every 4 weeks
measurement of % change of Urine GAG
次要结局
- Secondary Outcome(baseline, every 12 weeks)
研究者
研究点 (1)
Loading locations...
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