A Multi-centre, Open-label, Single-arm, Non-interventional Post-marketing Study to Investigate Safety and Clinical Parameters of Alhemo® Under Routine Clinical Practice in Japan
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 23
- 试验地点
- 7
- 主要终点
- Number of adverse reaction (AR)
研究概览
简要总结
The purpose of the study is to investigate the safety and effectiveness of Alhemo® in all participants under real-world clinical practice in Japan. Participants will get Alhemo® as prescribed by the study doctor. The study will last for about 2 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
- •The decision to initiate treatment with commercially available Alhemo® has been made by the patient/LAR and the treating physician before and independently from the decision to include the patient in this study
- •Male or female patients, regardless of age
- •Diagnosis with HAwI/HBwI
排除标准
- •- Previous participation in this study. Participation is defined as having given informed consent in this study
研究组 & 干预措施
Concizumab
Participants with haemophilia A or haemophilia B with inhibitors will be treated with commercially available Alhemo (Concizumab) according to routine clinical practice at the discretion of the treating physician. Recruitment will be completed after 4.5 years from the launch of Concizumab. The observation period for each participant is 2 years. Total duration of this study is about 6.5 years.
干预措施: Concizumab (Drug)
结局指标
主要结局
Number of adverse reaction (AR)
时间窗: From baseline (week 0) to end of study (week 104)
Measured as count of ARs.
次要结局
- Number of treated spontaneous and traumatic bleeding episodes(From baseline (week 0) to end of study (week 104))
- Number of serious adverse reaction (SAR)(From baseline (week 0) to end of study (week 104))
- Number of treated spontaneous and traumatic target joint bleeding episodes(From baseline (week 0) to end of study (week 104))
- Number of serious adverse event (SAE)(From baseline (week 0) to end of study (week 104))
- Number of thromboembolic adverse event (AE)(From baseline (week 0) to end of study (week 104))
- Number of shock/anaphylaxis AE(From baseline (week 0) to end of study (week 104))
- Number of all treatment requiring bleeding episode(From baseline (week 0) to end of study (week 104))