NCT03179748已完成不适用
Non-interventional, Multi-Centre, Post-Authorisation Safety Study With Novoeight®/NovoEight® (Turoctocog Alfa) in Mexican Haemophilia A Patients
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
- 10
- 试验地点
- 1
- 主要终点
- Frequency of adverse reactions
研究概览
简要总结
The trial is conducted in North America. The aim of the trial is to assess the safety of turoctocog alfa under conditions of routine clinical care in patients with haemophilia A in Mexico
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
- •Signed 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 haemophilia A
- •Age range is 0 years and above
- •The decision to initiate treatment with commercially available turoctocog alfa has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
排除标准
- •Previous participation in this study. Participation is defined as having given informed consent in this study
- •Known or suspected allergy to turoctocog alfa or related products
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
研究组 & 干预措施
turoctocog alfa
Patients with haemophilia A
干预措施: turoctocog alfa (Drug)
结局指标
主要结局
Frequency of adverse reactions
时间窗: 3-36 months after enrollment
Count and % of events
次要结局
- Frequency of adverse events(3-36 months after enrollment)
- Efficacy in treatment of bleeds(3-36 months after enrollment)
- Consumption of turoctocog alfa for prophylaxis(3-36 months after enrollment)
- Consumption of turoctocog alfa for treatment of bleeds(3-36 months after enrollment)
- Number of bleeding episodes(3-36 months after enrollment)
- Consumption of turoctocog alfa for surgery and post-surgical period(3-36 months after enrollment)
- Number of patients with confirmed inhibitors(3-36 months after enrollment)
- Number of patients with allergic/hypersensitivity reactions to turoctocog alfa(3-36 months after enrollment)
研究者
研究点 (1)
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