An Exploratory Non-interventional Study of Ex-vivo Spiking Followed by Thromboelastography as a Method for Predicting the Efficacy of Recombinant Activated Human FVII (rFVIIa, NovoSeven®) in Adult Congenital Haemophilia A or B Patients With Inhibitors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- ROTEM parameters obtained at baseline and with activated recombinant human factor VII
研究概览
简要总结
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the basal and spiked TEG® (Thromboelastography) or ROTEM® (Thromboelastometry) profiles of frequently bleeding haemophilia subjects with inhibitors in a non-bleeding state.
详细描述
The TEG parameters are: R time (Reaction Time), K time (K Time (arbitrary measurement)), a (a angle), MA (Maximum Amplitude) and LY30 (Lysis 30 min after MA) while the ROTEM parameters are: CT (Clotting Time), CFT (Clot Formation Time), a (a angle), MCF (Maximum Clot Firmness) and LI60 (Lysis index 60 min after CT)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of congenital haemophilia A or B with a FVIII:C clot activity or FIX:C clot activity, respectively, less than 5%
- •Presently use of activated recombinant human factor VII (NovoSeven®) as haemostatic agent for preventive treatment or treatment of bleeding episodes
- •A documented historical or present record for the presence of inhibitors to factor VIII or IX, respectively
- •A documented history of 2 or more joint bleeding episodes during the preceding 12 months
- •Subjects must be in a non-bleeding state (i.e. no clinical manifestations of active bleeds)
排除标准
- •Subjects who have received any haemostatic treatment for a bleeding episode within the last 7 days prior to this trial
- •Immune tolerance therapy within the last 30 days prior to this trial
- •Clinically relevant coagulation disorders other than congenital haemophilia A or B
- •Thrombocytopenia (platelet count below 60,000 platelets/mcl)
- •Prophylactic haemostatic treatment within 3 days prior to this trial
研究组 & 干预措施
Ex vivo
干预措施: eptacog alfa (activated) (Drug)
结局指标
主要结局
ROTEM parameters obtained at baseline and with activated recombinant human factor VII
TEG parameters obtained at baseline and with activated recombinant human factor VII
次要结局
未报告次要终点