NCT01461018已完成3 期
A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects With Primary Immunodeficiency
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 22
- 试验地点
- 11
- 主要终点
- Annualized rate of infection episodes
研究概览
简要总结
The purpose of this study is to assess the long-term efficacy, tolerability, and safety of IgPro20 in subjects with primary immunodeficiency (PID) as an extension to the preceding follow-up study ZLB07_001CR (NCT01458171).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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.
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.
结局指标
主要结局
Annualized rate of infection episodes
时间窗: Up to 36 months
次要结局
- Number of subjects with adverse events (AEs)(Up to 36 months)
- Percentage of subjects with adverse events (AEs)(Up to 36 months)
- Rate of AEs per infusion(Up to 36 months)
- Annualized rate of clinically documented serious bacterial infections (SBIs)(Up to 36 months)
- Number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections(Up to 36 months)
- Number of days of hospitalization due to infections(Up to 36 months)
- Duration of use of antibiotics for infection prophylaxis and treatment(Up to 36 months)
- Median serum IgG concentration(Up to 36 months)
研究者
研究点 (11)
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