EUCTR2010-022231-11-DE进行中（未招募）1 期
A Phase 3/4 Prospective Study to Characterize the Pharmacokinetics ofAlglucosidase Alfa in Patients Aged 8 Years of Age and Older - PAPAYA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 21
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
- •-A patient must meet all of the following criteria to be eligible for this study.
- •-The patient and/or the patient's parent/legal guardian is willing and
- •able to provide signed informed consent.
- •-The patient is =8 years of age with confirmed acid a-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 must agree to use a medically accepted method of contraception throughout the study.
- •-For patients previously treated with alglucosidase alfa the patient has received alglucosidase alfa for at least 6 months.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-A patient who meets any of the following criteria will be excluded from this study.
- •-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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