NCT01312636已完成不适用
A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Congenital FVII Deficiency - Registry for All Treated 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
- 36
- 主要终点
- Presence and/or the appearance of inhibiting antibodies to factor VII and/or therapy-related thrombosis on using NovoSeven® under normal clinical practice conditions
研究概览
简要总结
This study is conducted in Japan. The aim of this observational study is to evaluate the long-term safety and efficacy of activated recombinant human factor VII (NovoSeven®) in subjects with congenital FVII deficiency.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Congenital FVII deficiency
- •Never been treated with NovoSeven® before
- •Patients already in treatment with NovoSeven®
排除标准
- •History of hypersensitivity to any of the components in NovoSeven®
研究组 & 干预措施
A
干预措施: activated recombinant human factor VII (Drug)
结局指标
主要结局
Presence and/or the appearance of inhibiting antibodies to factor VII and/or therapy-related thrombosis on using NovoSeven® under normal clinical practice conditions
时间窗: once a year in years 1-4
次要结局
- To assess the treatment evaluation for bleeding episodes(year 1, year 4)
- To assess the course and outcome of pregnancy in women treated with novoseven(until 1 month after giving birth)
研究者
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