Subcutaneous Immune Globulin (SCIG 20%) and Facilitated Subcutaneous Immunoglobulin (fSCIG) Treatment in Polish Paediatric Patients With Primary Immunodeficiencies (PID) - Retrospective Medical Chart Review Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 96
- 试验地点
- 5
- 主要终点
- Number of Doses per Infusion
研究概览
简要总结
The purpose of this observational, multi-center, retrospective cohort study is to assess treatment patterns of Cuvitru (SCIG) 20 percent (%) and HyQvia (fSCIG) in polish pediatric participants with PID. The study will collect pediatric patient data. These data are gathered and collected during routine clinical care. As this is a non-interventional/observational study, no treatment/pharmacotherapy is provided as part of the study.
详细描述
Subcutaneous immune globulin (SCIG 20%) and facilitated subcutaneous immunoglobulin (fSCIG) treatment in Polish paediatric patients with primary immunodeficiencies (PID) - retrospective medical chart review study
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant eligibility is determined according to the following criteria prior to entry into the study:
- •The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- •Male or female participants with PID, aged less than (<)18 years treated with SCIG 20% or fSCIG..
- •Diagnosis of PID according to the criteria developed by the European Society for Immunodeficiencies (ESID) https://esid.org/About-ESID
- •Treatment period for 20% SCIG ranges from November 1, 2017 until June 30, 2020, and for fSCIG from July 1, 2018 until June 30, 2020.
排除标准
- 未提供
结局指标
主要结局
Number of Doses per Infusion
时间窗: From start of the study upto end of the study (6 months)
Number of Infusion Sites
时间窗: From start of the study upto end of the study (6 months)
Length of Needle
时间窗: From start of the study upto end of the study (6 months)
Length of needle used for infusions will be assessed.
Assessment of Person who Perform the Infusion
时间窗: From start of the study upto end of the study (6 months)
Assessment of person (parent/guardian or self) who performs the infusion will be assessed.
Infusion Volume
时间窗: From start of the study upto end of the study (6 months)
Method of Administration
时间窗: From start of the study upto end of the study (6 months)
Method of administration in participants will be through pump or rapid push.
Type of Pump
时间窗: From start of the study upto end of the study (6 months)
Treatment Interval per 4 Weeks
时间窗: From start of the study upto end of the study (6 months)
Total Infusion Volume per 4 Weeks
时间窗: From start of the study upto end of the study (6 months)
Total Dose per 4 weeks
时间窗: From start of the study upto end of the study (6 months)
Total dose administered per 4 weeks data will be assessed.
次要结局
未报告次要终点