A Randomised, Open-label, Multi-centre Trial Investigating the Intra-subject Variability of ROTEM® and TEG® Parameters Following Two Intravenous Administrations of the Same Dose of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Haemophilia Patients in a Non-bleeding State
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- TEG® (Thromboelastography) parameters after dosing of trial product
研究概览
简要总结
This trial is conducted in Asia and Europe. The aim of this trial is to evaluate the intra-subject variability of thromboelastographic parameters (TEG® and ROTEM®) following two administrations of activated recombinant human factor VII in haemophilia patients in a non bleeding state.
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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 (Activated Coagulation Factor VIIa Clotting activity) or FIX:C (Coagulation Factor IX Clotting activity) one stage activity, respectively, at less than 5% of normal (based on medical records) plus/minus inhibitors (a positive inhibitor status defined as 0.6 Bethesda units)
- •Non-bleeding state (i.e. no clinical manifestation of active bleed) at the time of administration of trial product
排除标准
- •Known or suspected allergy to trial product or any of its components or to related products
- •Known clinically relevant coagulation disorders or insufficiencies other than congenital haemophilia A or B
- •Platelet count below 50,000 platelets/mcL
- •Received any haemostatic treatment (e.g. Feiba) within the last 7 days prior to administration of trial product, except for activated recombinant human factor VII
研究组 & 干预措施
Low dose
干预措施: activated recombinant human factor VII (Drug)
Medium dose
干预措施: activated recombinant human factor VII (Drug)
High dose
干预措施: activated recombinant human factor VII (Drug)
结局指标
主要结局
TEG® (Thromboelastography) parameters after dosing of trial product
ROTEM® (Thromboelastometry) parameters after dosing of trial product
次要结局
- TEG® parameters obtained from blood samples spiked ex vivo with activated recombinant human factor VII
- ROTEM® parameters obtained from blood samples spiked ex vivo with activated recombinant human factor VII
- Serious adverse events and non-serious adverse events