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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Octapharma
- 入组人数
- 30
- 试验地点
- 24
- 主要终点
- To compare satisfaction (LQI questionnaire, factor I: treatment interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL by delivery device used.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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.
研究组 & 干预措施
Chrono Super PID then Generic Syringe - Gammanorm
Each patient will receive the study treatment using each of the two studied delivery devices according to the sequence randomly assigned based on a cross-over design:
• Chrono Super PID then Generic Syringe-Gammanorm
干预措施: Chrono Super PID then Generic Syringe-Gammanorm (Device)
Generic Syringe then Chrono Super PID - Gammanorm
Each patient will receive the study treatment using each of the two studied delivery devices according to the sequence randomly assigned based on a cross-over design:
• Generic Syringe then Chrono Super PID-Gammanorm
干预措施: Generic Syringe then Chrono Super PID-Gammanorm (Device)
结局指标
主要结局
To compare satisfaction (LQI questionnaire, factor I: treatment interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL by delivery device used.
时间窗: Participants will be followed for a total of 6 months
Each patient will be treated for two consecutive periods of three months each according to the sequence assigned based on the cross-over design (syringe and then pump, or pump and then syringe) without any intermediate washout period. The total duration of study treatment will therefore be 6 months for each patient. Assessment will be conducted via the LQI scale.
次要结局
- To compare the other quality of life scores(Participants will be followed for a total of 6 months)