Phase III Study of Immune Globulin Intravenous (Human) IGIV-SN in Pediatric Subjects With Primary Humoral Immunodeficiency
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Efficacy: Incidence of Acute SBIs (Serious Bacterial Infections)
研究概览
简要总结
To assess the safety, efficacy, and pharmacokinetics of IGIV-SN in pediatric subjects with primary immunodeficiency humoral diseases (PHID)
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
- 24 Months 至 203 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric subjects with a confirmed clinical diagnosis of a Primary Humoral Immunodeficiency Disease as defined by IUIS (International Union of Immunological Societies) and require treatment with IGIV. Documented agammaglobulinemia or hypogammaglobulinemia
- •Subject is willing to comply with all requirements of protocol
- •Authorization to access personal health information
排除标准
- •Subject has secondary immunodeficiency
- •Subject has a history of repeated reactions or hypersensitivity to IGIV or other injectable forms of IgG
- •Subject has significant protein loss from enteropathy, nephrotic syndrome or lymphangiectasia
结局指标
主要结局
Efficacy: Incidence of Acute SBIs (Serious Bacterial Infections)
时间窗: 13 months (12 months of treatment + 1 month of Follow-Up)
The incidence of acute serious bacterial infections, i.e. bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, osteomyelitis/ septic arthritis, visceral abscess
Safety: Overall Incidence of AEs that occur during 72 hours of following an infusion of test drug
时间窗: 13 months (12 months of treatment + 1 month of Follow-Up)
The overall incidence of adverse events (AEs) that occur during or within 1 hours, 24 hours, and 72 hours following an infusion of test product, regardless of whether or not the AE is determined to be product related
次要结局
- Efficacy: Incidence of Infections other than acute serious bacterial infections(13 months (12 months of treatment + 1 month of Follow-Up))
- Safety: The frequency of all AEs that occuring during the study(13 months (12 months of treatment + 1 month of Follow-Up))