EUCTR2005-001651-37-IT进行中（未招募）不适用
A phase IV, open label, non comparative, multicenter study to evaluate the long term efficacy and safety and tolerability of oral miglustat as a maintenance after a switch form enzyme replacement therapy ERT in adult patients with stable type 1 Gaucher disease - ND
Actelion Registration Ltd0 个研究点目标入组 50 人开始时间: 2006年3月14日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients aged 18 years or older with a confirmed diagnosis of type 1 mild to moderate gaucher disease. 2. Patients treated with ERT for at least 3 years and who are receiving their current dose for a minimum of last 6 month
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients who do not agree to use reliable contraception through out the study and for 3 month after cessation of miglustat treatment 2. Female patients who are pregnant or breast feeding. 3. Patients with a confirmed neuropathy 4. Patients with a severe renal impairments
研究者
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