Special Drug Use Surveillance Study of Ceprotin for Intravenous Injection 1000IU (All-Case Surveillance)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 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 conducted in Japan of Freeze-dried Human Protein C Concentrate (TAK-662) used to treat participants with congenital protein C deficiency.
The main aim of the study is to evaluate for adverse events and effectiveness of congenital protein C deficiency (TAK-662).
During the study, participants with congenital protein C deficiency will be administered with TAK-662 intravenous injection in under routine normal practice. The investigators will evaluate adverse events due to TAK-662 for 12 months. For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, the investigator will evaluate for 24 months as a maximum. The study sponsor will not be involved in how the participants are administered but will be recorded what happens during the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- All participants with congenital protein C deficiency who are administered with Freeze-dried Human Protein C Concentrate (TAK-662).
排除标准
- 未提供
研究组 & 干预措施
Freeze-dried Human Protein C Concentrate (TAK-662)
Participants will be administered Freeze-dried Human Protein C Concentrate (TAK-662) intravenous injection.
干预措施: Freeze-dried Human Protein C Concentrate (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 12 months (For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, up to 24 months as a maximum)
次要结局
- Number of Participants who Experience at Least One TEAE of Venous Thromboembolism(Up to 12 months (For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, up to 24 months as a maximum))
- Number of Participants who Experience at Least One TEAE of Purpura Fulminans(Up to 12 months (For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, up to 24 months as a maximum))