DRKS00008784已完成3 期
A randomised, cross-over study to compare quality of life and satisfaction in primary immunodeficient patients treated with subcutaneous injections of Gammanorm® 165 mg/mL administered with two different delivery devices: injections using pump or rapid push - GAN-06
Octapharma Pharmazeutika Prod.Ges.m.b.H. | Octapharma Pharmazeutika Prod.Ges.m.b.H | A-1100 Vienna Austria |0 个研究点目标入组 30 人开始时间: 2015年7月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one(—)
- 性别
- All
入选标准
- •Adult patients (= 18 years).
- •Presenting with primary immunodeficiency.
- •Having received subcutaneous injections of immunoglobulin at home using an automatic pump or syringe for at least 1 month at the time of inclusion.
- •For whom the investigator decides to maintain immunoglobulin replacement therapy with subcutaneous injections of Gammanorm® 165 mg/mL at home.
- •Freely given written informed consent from patient.
- •Women of childbearing potential must have a negative result on a pregnancy test (human chorionic gonadotropine [HCG]-based assay) and need to practice contraception using a method of proven reliability for the duration of the study
排除标准
- •Participating in another interventional clinical study and receiving investigational medicinal product within three months before study entry.
研究者
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