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临床试验/DRKS00008784
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

发起方
Octapharma Pharmazeutika Prod.Ges.m.b.H. | Octapharma Pharmazeutika Prod.Ges.m.b.H | A-1100 Vienna Austria |

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