Specified Drug Use Surveillance of FIRAZYR Subcutaneous Injection 30mg Syringe for Pediatric Subjects With Hereditary Angioedema (All-Case Investigation)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE)
研究概览
简要总结
This study is a survey in Japan of Icatibant subcutaneous injection 30 mg syringe used to treat children or teenagers with acute attacks of hereditary angioedema (HAE). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
The main aim of the study is to check for side effects related from Icatibant subcutaneous injection 30 mg syringe and to check if Icatibant subcutaneous injection 30 mg syringe improves acute attacks of HAE.
During the study, pediatric participants with HAE will take Icatibant subcutaneous injection 30mg syringe according to their clinic's standard practice. The study doctors will check for side effects from Icatibant subcutaneous injection 30 mg syringe for 3 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- All participants with HAE who are 2 to <18 years of age, treated with Icatibant subcutaneous injection 30 mg syringe for the first time.
排除标准
- •- Participants who have been treated with Icatibant subcutaneous injection 30 mg syringe in clinical trials or transfer cases, and so on.
研究组 & 干预措施
Icatibant
Participants will be recieved Icatibant 10 to 30 mg injection subcutaneously.
干预措施: Icatibant (Drug)
结局指标
主要结局
Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE)
时间窗: Up to 3 Months
次要结局
- Time from Onset of Seizure to Start of Treatment(Up to 3 Months)
- Time from First Drug Administration to Symptom Resolution(Up to 3 Months)
- Duration of Seizure(Up to 3 Months)