EUCTR2014-004995-49-PL进行中(未招募)1 期
An Open-label, Multicenter, Multinational Extension Study of the Long-term Safety, Pharmacodynamics, and Exploratory Efficacy of GZ/SAR402671 in Adult Male Patients Diagnosed with Fabry Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 11
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
入选标准
- •Male patient with Fabry disease who previously completed study ACT13739.
- •Patients, willing and able to provide signed informed consent.
- •Sexually active patients, willing to practice true abstinence in line with their preferred and usual lifestyle or using two acceptable effective methods of contraception.
- •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 8
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients, in the opinion of the Investigator, unable to adhere to the requirements of the study.
研究者
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