NCT02207218已完成不适用
A Multicentre, Non-interventional Post Marketing Study of Safety and Efficacy of NovoEight® (rFVIII) During Long-Term Treatment of Haemophilia A in Japan
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Frequency of Adverse Events (AEs)
研究概览
简要总结
This study is conducted in Asia. The aim of this study is to evaluate the safety and efficacy of NovoEight® (recombinant factor VIII) in patients with haemophilia A in Japan in the setting of routine clinical practice.
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
- •Informed consent obtained before any study-related activities. Study-related activities are any procedure related to recording of data according to the protocol
- •Male and female patients with the diagnosis of haemophilia A
- •Age range is 0 year and above
- •A decision to initiate treatment with commercially available NovoEight® has been made by the patient/parent and the physician
排除标准
- •Known or suspected allergy to study product(s) or related products
- •Previous participation in this study. Participation is defined as informed consent obtained
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
研究组 & 干预措施
NovoEight®
干预措施: turoctocog alfa (Drug)
结局指标
主要结局
Frequency of Adverse Events (AEs)
时间窗: Week 0- 104
次要结局
- Frequency of Serious Adverse Events (SAEs)(Week 0- 104)
- Consumption of NovoEight® per month (IU/kg BW/month) for prevention(Week 0- 104)
- Frequency of Serious Adverse Reactions (SARs)(Week 0- 104)
- Haemostatic effect of NovoEight® during surgical procedures assessed by evaluation according to a predefined four point scale: Excellent, Good, Moderate, or None(Week 0- 104)
- Annualised bleeding rate for patients using NovoEight® for preventive regimen(Week 0- 104)
- Total consumption of NovoEight® per patient (prevention, treatment of bleeds and surgery) per year (IU/kg BW/year/patient)(Week 0- 104)
- Consumption of NovoEight® (IU/kg BW) from the day of surgery until the day of return to preventive regimen or on-demand treatment regimen(Week 0- 104)
- Frequency of Adverse Reactions (ARs)(Week 0- 104)
- Haemostatic effect of NovoEight® in the treatment of bleeds according to a predefined four point scale: Excellent, Good, Moderate, or None for patients with preventive regimen and on-demand treatment regimen, respectively(Week 0- 104)
- Consumption of NovoEight® per bleed (IU/kg BW/bleeding episode)(Week 0- 104)
研究者
研究点 (1)
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