NCT02670213已完成不适用
A Multicentre, Non-interventional Post Marketing Study of Safety and Effectiveness of NovoThirteenR (rFXIII) During Treatment of Congenital FXIII Deficiency 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
- 8
- 试验地点
- 8
- 主要终点
- Adverse drug reactions in patients with congenital FXIII A-subunit deficiency treated with NovoThirteen®, comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of therapeutic effect
研究概览
简要总结
This study is conducted in Asia. Tha aim of this study is to investigate Safety and Effectiveness of NovoThirteen® (rFXIII) during treatment of congenital FXIII deficiency in Japan.
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
- •Male of female patients, regardless of age, requiring treatment with NovoThirteenR for whom the treating physician has decided to use NovoThirteenR (rFXIII) treatment
排除标准
- 未提供
研究组 & 干预措施
NovoThirteen®
干预措施: recombinant factor XIII (Drug)
结局指标
主要结局
Adverse drug reactions in patients with congenital FXIII A-subunit deficiency treated with NovoThirteen®, comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of therapeutic effect
时间窗: Year 0-9
次要结局
- All technical complaints(Year 0-9)
- Frequency of bleeding episodes(Year 0-9)
- All serious adverse events(Year 0-9)
- All adverse events(Year 0-9)
- All medical event of special interest(Year 0-9)
- All medication errors collected(Year 0-9)
- Use of NovoThirteen® for other uses than for the approved indication(Year 0-9)
研究者
研究点 (8)
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