DRKS00014562已完成不适用
on-interventional study on the usage and outcomes of CUVITRU in patients with Primary Immunodeficiency Diseases - CORE CUVITR
GWT-TUD GmbH, Abteilung Medizin0 个研究点目标入组 36 人开始时间: 2018年4月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- one 至 one（—）
- 性别
- All
入选标准
- •1. Patient with a documented diagnosis of a form of primary humoral immunodeficiency (PID) involving a defect in antibody formation and requiring gammaglobulin replacement
- •2. Subject has received any SCIG (subcutaneous immunoglobulin) product previous to CUVITRU for at least 3 month at a stable dose
- •3. Subject has received CUVITRU in line with the product specification (labelling) at the time of first documentation and is expected to continue treatment with this therapy in future
- •4. Subject or legally authorized representative has provided written informed consent
- •5. Subject is likely and willing to be available for follow-up documentation including patient-reported assessments
排除标准
- •1. Subject has experienced a dose change during 3 month previous to the time of CUVITRU initiation
- •2. Subject participates in a clinical study in parallel during the observation period
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