NCT02180763已完成4 期
A Randomized, Cross-over Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL According to the Delivery Device: Injections Using Pump or Rapid Push.
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Octapharma
- 入组人数
- 31
- 试验地点
- 8
- 主要终点
- "Life Quality Index" (LQI) score (factor I: treatment interference)
研究概览
简要总结
The purpose of this study is to compare satisfaction (LQI questionnaire, factor I: treatment interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL according to the delivery device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 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
- •Having signed an informed consent form
排除标准
- •Patient currently participating in another interventional study at the time of inclusion
研究组 & 干预措施
Gammanorm® 165 mg/mL
Experimental
干预措施: Gammanorm (Biological)
结局指标
主要结局
"Life Quality Index" (LQI) score (factor I: treatment interference)
时间窗: 6 Months
Primary endpoint for assessment of patient's satisfaction regarding the treatment delivery device (pump or syringe) will be the "Life Quality Index" (LQI) score (factor I: treatment interference) at the end of each 3-month treatment period.
次要结局
未报告次要终点
研究者
研究点 (8)
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