IRCT2014112420051N4已完成3 期
Prospective, open-label, uncontrolled, Phase III study to assess the efficacy and safety of Octafibrin for on-demand treatment of acute bleeding and to prevent bleeding during and after surgery in subjects with congenital fibrinogen deficiency”
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 years 至 no limit（—）
- 性别
- All
入选标准
- •Aged =12 years ; Documented diagnosis of congenital fibrinogen deficiency, expected to require on-demand treatment for bleeding or surgical prophylaxis :Fibrinogen deficiency manifested as afibrinogenaemia or severe hypofibrinogenaemia; Expected to have an acute bleeding episode (spontaneous or after trauma) or planning to undergo elective surgery.
- •Exclusion criteria: Life expectancy <6 months ;Other Congenital Bleeding disorders ;Prophylactic treatment with a fibrinogen concentrate ;Treatment with any fibrinogen concentrate or other fibrinogen-containing blood product within 2 weeks prior to start of treatment for the bleeding episode or surgery.
- •Treatment with any coagulation-active drug (within 1 week prior to 24 hours after start of treatment
排除标准
- 未提供
研究者
相似试验
进行中（未招募）
1 期
A study of the effectiveness and safety of Octafibrin, a replacement for fibrinogen, in patients with inherited fibrinogen deficiency causing episodes of bleeding.EUCTR2011-002419-27-GBOctapharma AG25
进行中（未招募）
1 期
A study of the effectiveness and safety of Octafibrin, a replacement for fibrinogen, in patients with inherited fibrinogen deficiency causing episodes of bleeding.EUCTR2011-002419-27-BGOctapharma AG24
进行中（未招募）
3 期
To study the effect of Octafibrin (i.e. human plasma fibrinogen concentrate, which is a product derived from blood) in paediatric subjects with congenital fibrinogen deficiency (a rare bleeding disorder).CTRI/2015/07/005953Octapharma AG4
进行中（未招募）
3 期
A clinical trial to study the efficacy and safety of Octafibrin for on-demand treatment of acute bleeding and to prevent bleeding during and after surgery in subjects with congenital fibrinogen deficiency.CTRI/2014/09/005074Octapharma AG
已完成
3 期
The effect of haemostatic factor,Octafibrin in congenital afibrinogenemiaIRCT2014112320051N3Octapharma3