EUCTR2014-002158-38-FR进行中（未招募）不适用
A Study of Respiratory Muscle Strength, including Effort-Independent Measures, in Subjects with Late-Onset Pompe Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
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
- •Willing and able to provide written informed consent, after the nature of the study has been explained, and prior to any study-related procedures
- •Documented diagnosis with late-onset Pompe disease based on GAA gene mutations and/or endogenous GAA activity <75% of the lower limit of the normal adult range reported by the testing laboratory, assessed by dried blood spot or whole-blood assay
- •At least 18 years of age at study entry
- •Willing and able to comply with all study procedures
- •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 15
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Requires ventilatory support while awake and in the upright position
- •Concurrent disease, medical condition, or extenuating circumstance that, in the opinion of the investigator, might compromise patient well-being, study completion, or data collection
- •Swallowing difficulty precluding balloon catheter placement (eg, esophageal strictures)
- •Allergy to tools or procedures used for respiratory muscle testing
- •Implanted ferrous metals (eg, cardiac pacemakers)
研究者
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