NL-OMON51818招募中不适用
Clinical Survey Study to Assess Physical Function and the Incidence of Hypoglycemia in Patients 1 Year of Age and Over with GSD III. - UX053-CL002
ltragenyx pharmaceutical Inc.0 个研究点目标入组 2 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0 至 99（—）
入选标准
- •1. Male or female 1 year of age or older at time of informed consent/assent
- •2. Diagnosis of GSD III, confirmed by AGL sequencing or GDE enzymatic testing
- •3. Provide informed consent after the nature of the study has been explained,
- •and prior to
- •any research-related procedures. If a minor or an adult with cognitive
- •limitations, willing
- •and able (if possible) to provide assent and have a legally authorized
- •representative
- •provide informed consent after the nature of the study has been explained, and
- •any research-related procedures
排除标准
- •1. Subject is unwilling to remain blinded to CGM data, or the Investigator
- •determines that blinding would compromise subject safety
- •2. Presence or history of any condition that, in the view of the Investigator,
- •would interfere with participation or pose undue risk
- •3. Use of any IP or investigational medical device within 30 days or 5.5
- •half-lives, whichever is longer, prior to screening, or during the study
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