EUCTR2012-005727-32-NL进行中（未招募）不适用
Pharmacokinetics and safety of the intravenous human immunoglobulin product Nanogam 100 mg/ml - PK and safety of Nanogam 100 mg/ml
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Primary a- or hypogammaglobulinemia, particularly patients with XLA or CVID
- •- Stabilised on treatment with Nanogam® 50 mg/ml with 3-4 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 and older
- •- The patient/legally acceptable representative has signed the consent form
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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
研究者
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