Pharmacokinetics and Safety of the Intravenous Human Immunoglobulin Product Nanogam 100 mg/ml
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- Cmax
研究概览
简要总结
Intravenous immunoglobulin (IVIG) is used for treatment of a heterogeneous group of immune related disorders both as immune-replacement and immune-modulating therapy. Sanquin developed a 100 mg/ml IVIg product (Nanogam 100 mg/ml). Patient will receive one infusion with Nanogam 50 mg/ml as they used to (same dose) and subsequently 4 infusions with Nanogam 100 mg/ml (same dose). Aim is to show bioequivalency between the 50 mg/ml and the 100 mg/ml product of Sanquin.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary a- or hypogammaglobulinemia, particularly patients with XLA or CVID
- •Stabilised on treatment with Nanogam 50 mg/ml with 2-4 weeks intervals in an hospital or at home and willing to be treated with 1 infusion of Nanogam 50 mg/ml and 4 infusions of Nanogam 100 mg/ml at the hospital
- •A stable clinical situation (no activity of any other disease; a stable immunoglobulin dose and frequency)
- •Age >= 18 years
- •The patient has signed the consent form
排除标准
- •Known with allergic reactions against human plasma or plasma products
- •Having an ongoing progressive disease, including HIV infection
- •Pregnancy or lactation
- •Known with insufficiency of coronary or cerebral circulation
- •Having renal insufficiency (plasma creatinin > 115µmol/L)
- •Having IgA deficiency and anti-IgA antibodies have been detected
研究组 & 干预措施
Intravenous immunoglobulin infusion
One intravenous infusion with Nanogam 50 mg/ml and 4 with Nanogam 100 mg/ml (0.2-0.8 g/kg)
干预措施: Intravenous immunoglobulin infusion (Drug)
结局指标
主要结局
Cmax
时间窗: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Comparison IVIG 5% and 10%
elimination rate constant(s)
时间窗: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Comparison IVIG 5% and 10%
half-life
时间窗: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Comparison IVIG 5% and 10%
IgG trough levels
时间窗: before infusion
Comparison IVIG 5% and 10%
plasma concentration-time curve
时间窗: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Comparison IVIG 5% and 10%
area under the curve
时间窗: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Comparison IVIG 5% and 10%
volume of distribution
时间窗: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Comparison IVIG 5% and 10%
Tmax
时间窗: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Comparison IVIG 5% and 10%
次要结局
- Adverse Events(from first till 3 weeks after last infusion (11-19 weeks dependent on infusion frequency))