CTRI/2014/11/005189已完成4 期
A Phase 4 Prospective Study to Characterize the Pharmacokinetics of Alglucosidase Alfa in Patients Aged 8-18 Years of Age - PAPAYA
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •A patient must meet all of the following criteria to be eligible for this study.
- •The patient and/or the patientââ?¬•s parent/legal guardian is willing and able to provide signed informed consent.
- •The patient is ââ?°Â¥8 and ââ?°Â¤18 years of age with confirmed acid Ã?±-glucosidase [GAA] enzyme deficiency from skin, blood, or muscle tissue and/or 2 confirmed GAA gene mutations.
- •The patient, if female and of childbearing potential, must have a negative pregnancy test (urine beta-human chorionic gonadotropin) at baseline. Note: All female patients of childbearing potential and sexually mature males
排除标准
- •A patient who meets any of the following criteria will be excluded from this study.
- •The patient has had previous treatment with alglucosidase alfa.
- •The patient is participating in another clinical study using an investigational product.
- •The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the study.
研究者
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