NCT01166074已完成不适用
Retrospective Chart Review Study: Subcutaneous IgG in Children Under 2 Years of Age
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 27
- 试验地点
- 5
- 主要终点
- SCIG use
研究概览
简要总结
This study is a retrospective chart review of the use of subcutaneous IgG (SCIG) in infants less than two years old.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants who received more than one dose of IgG by the subcutaneous route before the age of two years.
- •Consent of parent/guardian if required by institution/IRB.
排除标准
- •Infants with protein losing conditions such as lymphangiectasis, nephrosis, S/P cardio-thoracic surgery requiring drainage tubes for more than 48 hrs, protein losing enteropathy.
- •Concomitant treatment with plasma, other blood products or IGIV while on SCIG.
- •Lack of consent by parent/guardian (if required by Institution/IRB).
- •Any other condition or treatment which, in the opinion of the local investigator, would interfere with obtaining valid results for that subject.
结局指标
主要结局
SCIG use
时间窗: 1 year
To describe the use of SCIG in infants below the age of two years in major academic medical centers and immunologists' practices in the US
次要结局
- Number of infants who received more than one dose of SCIG, then continued receiving IgG by a route other than SC(1 year)
研究者
研究点 (5)
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