EUCTR2009-013762-63-SE进行中（未招募）不适用
A phase I/IIa, open label, escalating dose, pilot study to assess the effect, safety, tolerability and pharmacokinetics of multiple subcutaneous and intravenous doses of PRO044 in patients with Duchenne muscular dystrophy
Prosensa Therapeutics B.V0 个研究点目标入组 24 人开始时间: 2009年11月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
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
- Male
入选标准
- •1.Age at least 5 and not older than 16 years on the day of first drug administration
- •2.Duchenne muscular dystrophy resulting from a mutation correctable by treatment with PRO044
- •3.Life expectancy at least 6 months after inclusion in the trial
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 24
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Ventilator dependency
- •2. Previous treatment with investigational medicinal treatment within 6 months prior to the start of the pre-screening for the study
- •3. Previous treatment with idebenone within 6 months prior to the start of the pre-screening for the study.
研究者
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