EUCTR2016-001631-12-Outside-EU/EEA进行中（未招募）1 期
Prospective open-label single-arm study of the pharmacokinetics and safety of intravenous IgPro10 in Japanese subjects with primary immunodeficiency
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
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
- •1. Male or female Japanese subject with a diagnosis of PID. 2. Aged = 6 years with body weight = 19 kg at the time of providing written informed consent/minor assent. 3. Previously receiving stable doses of any intravenous immunoglobulin (IVIG) product currently approved in Japan for at least 6 months prior to study entry at regular 3- or 4-weekly intervals. 4. At least 1 historic IgG trough level of = 5 g/L during the past 6 months prior to study entry (can be obtained at Screening).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 6
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 6
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Newly diagnosed PID. 2. Ongoing active serious infection at the time of Screening (e.g., pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess). 3. Ongoing or history of concomitant malignancies of lymphoid cells such as lymphocytic leukemia, non-Hodgkin's lymphoma and immunodeficiency with lymphoma. 4. Known hyperprolinemia, hypoalbuminemia, protein-losing enteropathies, and any proteinuria.
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