NL-OMON38799已完成3 期
Pharmacokinetics and safety of the intravenous human immunoglobulin product Nanogam 100 mg/ml - PK and safety of Nanogam 100 mg/ml
Sanquin Bloedvoorziening0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 or older
- •- 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
研究者
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