NCT02247154已完成4 期
A Study of the Safety and Efficacy of an Intravenous Immunoglobulin (Vigam® Liquid) in Patients With Primary or Secondary Antibody Deficiency.
Bio Products Laboratory8 个研究点 分布在 1 个国家开始时间: 1999年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 试验地点
- 8
- 主要终点
- IgG half-life
研究概览
简要总结
To determine:
- The safety of Vigam® Liquid in patients with primary or secondary antibody deficiency (PAD or SAD).
- The efficacy of Vigam® Liquid in patients with primary or secondary antibody deficiency.
- The half-life of Vigam® Liquid after 4 months of treatment.
- The subclass and total gammaglobulin concentrations after each infusion of Vigam® Liquid.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18-80 years) with PAD or SAD
- •With a low serum IgG (<6 g/l) and a history of recurrent infections
- •Requiring and eligible for polyvalent intravenous immunoglobulin (IVIG) replacement therapy
- •Non-reactive for HBsAg and with an alanine aminotransferase (ALT) level less than twice upper limit of normal prior to entry into the trial
排除标准
- 未提供
研究组 & 干预措施
Vigam® Liquid
Experimental
干预措施: Vigam® (Human Normal Immunoglobulin) (Biological)
结局指标
主要结局
IgG half-life
时间窗: Pre-dose, 5 min, 1, 2, 4, 7, 10, 14, 21 days post-dose
次要结局
未报告次要终点
研究者
研究点 (8)
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