Observational Study on the Safety of Hemlibra Subcutaneous Injection in Korean Hemophilia A Patients With/Without FVIII Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
To evaluate Safety and efficacy and pharmacokinetics, FVIII Inhibitor titers of Hemlibra subcutaneous injection (SC inj.) in Korean Hemophilia A patients with/without FVIII Inhibitors.
详细描述
Target subject :
- Patients with Hemophilia A with FVIII inhibitors
- Patients with severe Hemophilia A without FVIII inhibitors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Hemophilia A (congenital factor VIII deficiency) who will receive Hemlibra SC inj. according to medical decision by investigator
- •Signed informed consent form
排除标准
- •Subjects who are hypersensitive to Emicizumab
- •Subjects who are hypersensitive to mouse or hamster protein
- •Subjects with myocardial infarction or the history who are prohibited from administering L-Arginine containing drug
- •Subjects who participated in other clinical trials within a month before enrollment (or the first administration of Hemlibra SC inj.) (Unable to participate in other clinical trials related to Hemophilia A treatment even after enrollment)
- •Subjects who the investigator deems inappropriate for the study.
- •Moderate/Mild for Hemophilia A patients without FVIII inhibitors
研究组 & 干预措施
Hemophilia A with FVIII inhibitors
Hemophilia A patients with FVIII inhibitors will administer Emicizumab at a loading dose of 3 mg/kg/week SC for the first 4 weeks of treatment followed by 1.5 mg/kg QW SC or 3mg/kg Q2W or 6mg/kg Q4W
干预措施: Emicizumab subcutaneous injection (Drug)
Hemophilia A without FVIII inhibitors
Hemophilia A patients without FVIII inhibitors will administer Emicizumab at a loading dose of 3 mg/kg/week SC for the first 4 weeks of treatment followed by 1.5 mg/kg QW SC or 3mg/kg Q2W or 6mg/kg Q4W
干预措施: Emicizumab subcutaneous injection (Drug)
结局指标
主要结局
Adverse events
时间窗: for 24weeks
AEs will be described for AEs and Adverse Drug Reactions (ADRs), Adverse Events of Special Interest (AESIs), other important AEs. Severity, outcome, causal relationship with study drug, etc. of AEs will be analyzed.
次要结局
- Annualized Bleeding episode Rate (ABR)(for 24weeks)