An Open-label Single- and Multiple-dose Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa Following i.v. Administration of One Dose of 270 Microg/kg and Three Doses of 90 Microg/kg in Patients With Haemophilia A or B With or Without Inhibitors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- Thromboelastography (TEG) parameter Maximum Thrombosis Generation (MTG;'maximum velocity')
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of rFVIIa (activated coagulation factor VII) following one single injection of 270 microg/kg compared to three injections of 90 microg/kg rFVIIa in patients with haemophilia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- •Male patients with confirmed diagnosis of severe congenital haemophilia A or B (higher than 1% FVIII or FIX) with or without inhibitors to coagulation factors VIII or IX, based on medical records
排除标准
- •Congenital or acquired coagulation disorder other than congenital haemophilia A or B
- •Any clinical signs or known history of arterial thrombotic events or previous deep vein thrombosis or pulmonary embolism (as defined by available medical records)
- •Use of any anticoagulant (e.g. un-fractionated or low molecular weight heparin, vitamin-K antagonists, direct thrombin inhibitors or factor Xa inhibitors)
- •Bleeding prophylactic treatment or FVIII or FIX immune tolerance induction (ITI) treatment during the trial period
研究组 & 干预措施
270 microg/kg rFVIIa
Each subject will receive one single injection of 270 microg/kg and three injections of 90 microg/kg rFVIIa (one injection every 3 hours) in a randomised order. The two administration days will be separated by a wash-out period of at least 48 hours
干预措施: eptacog alfa (activated) (Drug)
3x90 microg/kg rFVIIa
Each subject will receive one single injection of 270 microg/kg and three injections of 90 microg/kg rFVIIa (one injection every 3 hours) in a randomised order. The two administration days will be separated by a wash-out period of at least 48 hours
干预措施: eptacog alfa (activated) (Drug)
结局指标
主要结局
Thromboelastography (TEG) parameter Maximum Thrombosis Generation (MTG;'maximum velocity')
时间窗: 10 minutes post-dose for 270 microg/kg and 10 minutes after the first injection of 90 microg/kg
次要结局
- TEG parameters r-time, MTG, alpha angle, and maximum amplitude (MA)(Prior to and 24 hours following the administrtion of 270 microg/kg and each of the 3 administrations of 90 microg/kg)