EUCTR2017-003153-42-Outside-EU/EEA进行中（未招募）1 期
Extension Study of Protocol ENB-006-09 Evaluating the Long-Term Safety and Efficacy ofAsfotase Alfa (Human Recombinant Tissue-Nonspecific Alkaline Phosphatase Fusion Protein) in Children with Hypophosphatasia (HPP)
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
- 12
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
- •Patients must meet all of the following criteria for enrollment in this study:
- •? Compliant and satisfactory completion of Alexion-sponsored clinical trial ENB-006-09
- •? Written informed consent by parent or other legal guardian) prior to any study procedures being performed
- •? Parent or other legal guardian willing to comply with study requirements
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients will be excluded from enrollment in this study if they meet any of the following exclusion criteria:
- •? Clinically significant disease that precludes study participation, in the Investigator’s opinion
- •? Treatment with an investigational drug other than asfotase alfa
- •? Prior treatment with bisphosphonates
- •? Enrollment in any study (other than ENB-006-09) involving an investigational drug, device, or treatment
研究者
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