NCT01422187已完成3 期
A Multicenter Extension Study of Taliglucerase Alfa in Adult Subjects With Gaucher Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 19
- 主要终点
- Spleen Volume
研究概览
简要总结
This is a multi-center trial to further extend the assessment of the safety and efficacy of taliglucerase alfa in adult subjects (≥18 years old) with Gaucher disease who have enrolled in Protocol PB-06-003. Subjects will continue to receive an intravenous (IV) infusion of taliglucerase alfa every two weeks. The duration of treatment will be a maximum of 21 months or until taliglucerase alfa is commercially available to the subject at the discretion of the Sponsor.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Successfully completed Protocol PB-06-001 and enrolled in Protocol PB-06-003
- •The subject signs an informed consent
排除标准
- •Currently taking another investigational drug for any condition.
- •Presence of any medical, emotional, behavioral or psychological condition that in the judgment of the Investigator would interfere with the subject's compliance with the requirements of the study.
研究组 & 干预措施
Taliglucerase alfa 30 units/kg
Experimental
Subjects randomized to receive 30 units/kg
干预措施: Taliglucerase alfa (Drug)
Taliglucerase alfa 60 units/kg
Experimental
Subjects randomized to 60 units/kg
干预措施: Taliglucerase alfa (Drug)
结局指标
主要结局
Spleen Volume
时间窗: 60 months
Spleen volume measured by MRI
次要结局
- Hemoglobin(60 months)
- Liver Volume(60 months)
- Platelet Count(60 months)
研究者
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进行中（未招募）
1 期
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