NL-OMON54552招募中3 期
A Phase 3 Open-label Extension Study to Assess the Long-term Safety and Efficacy of Intravenous ATB200 Co-administered With Oral AT2221 in Adult Subjects With Late-onset Pompe Disease - ATB200-07 Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subject must provide signed informed consent prior to any study-related
- •procedures being performed. If the subject is under 20 years of age, the
- •subject must provide written informed consent.
- •2. Subject must have completed Study ATB200-03.
- •Note: Subjects who were forced to withdraw from Study ATB200-03 for a
- •logistical reason not related to the efficacy or safety of ATB200/AT2221 (eg,
- •hospitalization for a car accident or emergency surgery) and which resulted in
- •several consecutive missed doses may be eligible to participate in this study
- •upon approval by the Amicus medical monitor.
- •3. Female subjects of childbearing potential and male subjects must agree to
- •use medically accepted methods of contraception during the study and for 90
- •days after the last dose of study drug.
排除标准
- •1. Subject plans to receive gene therapy or participate in another
- •interventional study for Pompe disease.
- •2. Subject has a hypersensitivity to any excipients in ATB200 or ATB2221 or
- •medical condition or any other extenuating circumstance that may, in the
- •opinion of the investigator or medical monitor, pose an undue safety risk to
- •the subject or may compromise his/her ability to comply with or adversely
- •impact protocol requirements. This includes clinical depression (as diagnosed
- •by a psychiatrist or other mental health professional) with uncontrolled or
- •poorly controlled symptoms.
- •3. Subject, if female, is pregnant or breastfeeding.
- •4. Subject, whether male or female, is planning to conceive a child during the
研究者
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