NCT02247141已完成3 期
A Multi-centre Open Study to Assess the Safety and Efficacy of Subgam® Given Via the Subcutaneous Route in Primary Antibody Deficient Patients.
Bio Products Laboratory14 个研究点 分布在 1 个国家开始时间: 2000年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 试验地点
- 14
- 主要终点
- Proportion of trough levels at each time point where serum IgG was more than equal to 4 g/L
研究概览
简要总结
The primary objective was to determine the efficacy of Human Normal Immunoglobulin (Subgam®) given subcutaneously by weekly infusion to patients with primary antibody deficiency.
The secondary objective was to determine the safety of Subgam® given subcutaneously by weekly infusion to patients with primary antibody deficiency.
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The main criteria for inclusion in the study were as follows:
- •A diagnosis of primary antibody deficiency;
- •No lower or upper age limit (any age was eligible);
- •With stable disease and receiving immunoglobulin (IVIG or SCIG) therapy for at least six months prior to starting the study;
- •Written informed consent (patient/parent/guardian).
排除标准
- 未提供
研究组 & 干预措施
Subgam®
Experimental
干预措施: Subgam® (Human Normal Immunoglobulin Solution) (Biological)
结局指标
主要结局
Proportion of trough levels at each time point where serum IgG was more than equal to 4 g/L
时间窗: Before each infusion in the first 6 months of the study (approximately 30 infusions)
次要结局
未报告次要终点
研究者
研究点 (14)
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