Post-marketing Database Survey: A Cohort Study to Evaluate the Safety of Cuvitru in Patients With Primary Immunodeficiency Using the PIDJ2 (Primary Immunodeficiency Database in Japan) Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Participants Who Experience Anaphylactic Reaction as an Adverse Event (AE)
研究概览
简要总结
This study is a retrospective database study in Japan to evaluate the safety of Immune Globulin Subcutaneous (Human), 20% Solution in participants with primary immunodeficiency disease (PID). This survey will conduct in use of medical database called PIDJ2.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary immunodeficiency (PID) enrolled in the PID patient registry.
- •Participant for whom study drug is entered in the therapeutic drug field on the data set.
- •Participant who is entered the intractable disease diagnosis corresponding to PID in the intractable disease information field.
- •Participant for whom the presence or absence of adverse events has been entered in the column of adverse events.
排除标准
- •Participant for whom study drug has not been entered in the drug name in the medical history field during the period from January 24, 2024 to January 23,
- •Participant who is not entered the intractable disease diagnosis corresponding to PID in the intractable disease information field.
- •Participant for whom the presence or absence of adverse events has not been entered in the column of adverse events.
研究组 & 干预措施
Immune Globulin Subcutaneous (Human), 20% Solution
Participants with primary immunodeficiency disease who received Immune Globulin Subcutaneous (Human) 20% infusion in accordance with package insert.
干预措施: Immune Globulin Subcutaneous (Human), 20% Solution (Drug)
结局指标
主要结局
Number of Participants Who Experience Anaphylactic Reaction as an Adverse Event (AE)
时间窗: From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)
An AE is defined as any untoward event that occurred in a participant after the first dose of study drug, which does not necessarily have a causal relationship with primary immunodeficiency disease. Number of participants who experience anaphylactic reaction as an AE will be reported.
Number of Participants Who Experience Thromboembolism as an AE
时间窗: From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)
An AE is defined as any untoward event that occurred in a participant after the first dose of study drug, which does not necessarily have a causal relationship with primary immunodeficiency disease. Number of participants who experience thromboembolism as an AE will be reported.
Number of Participants Who Experience Aseptic Meningitis as an AE
时间窗: From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)
An AE is defined as any untoward event that occurred in a participant after the first dose of study drug, which does not necessarily have a causal relationship with primary immunodeficiency disease. Number of participants who experience aseptic meningitis as an AE will be reported.
次要结局
未报告次要终点