EUCTR2014-003409-13-Outside-EU/EEA进行中（未招募）不适用
A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects with Primary Immunodeficiency
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- CSL Behring
- 入组人数
- 22
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
- •- Subjects who have completed the preceding follow-up study ZLB07_001CR.
- •- Written informed consent by the subject/parent/legally acceptable representative. Written assent for an underage subject (=7 years and <20 years of age at the time of obtaining informed consent), according to the competencies of the subject.
- •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 12
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Pregnancy or nursing mother.
- •- Participation in a study with an investigational medicinal product (IMP) within 3 months prior to enrollment except for study ZLB07_001CR.
- •- Subjects who are planning to donate blood during the study.
- •- Known or suspected antibodies to the IMP, or to excipients of the IMP.
- •- Treatment with another immunoglobulin G (IgG) within 3 months prior to the study.
研究者
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