NCT00922792已完成1 期
An Open, Non-Randomised Single and Multiple Dose Trial Investigating the Safety and Pharmacokinetics of Intravenous Administration of Long Acting rFVIIa (LA-rFVIIa) in Patients With Haemophilia A and B
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 主要终点
- Frequency of serious adverse events
研究概览
简要总结
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the effect of the body on the investigated drug) of long acting activated recombinant human factor VII (LA-rFVIIa) in patients with haemophilia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Haemophilia A or B
- •Bodyweight max 100 kg
- •Body Mass Index (BMI) max 30 kg/m2
- •Adequate venous access
排除标准
- •Known or suspected allergy to trial product(s) or related products (including NovoSeven®)
- •The receipt of any investigational product within 30 days prior to enrolment in this trial
- •Receipt of Immune Tolerance Induction (ITI) within the last 1 month prior to participation in this trial
- •The receipt of any haemostatic treatment for control of a bleeding episode within the last 5 days prior to administration of trial product
- •Receipt of FVIII or FIX replacement therapy within 48 hours prior to trial product administration
- •Known pseudo tumours
- •Congenital or acquired coagulation disorders other than haemophilia A or B
- •Any major and/or orthopaedic surgery within one month prior to trial start
- •Advanced atherosclerotic disease (defined as known history of ischemic heart disease, ischemic stroke, etc.)
- •Clinical signs of renal dysfunction
- •Use of platelet inhibitors, including NSAIDs, one week prior to administration of trial drug
- •Use of non-prescribed opiate substances
研究组 & 干预措施
A
Experimental
干预措施: activated recombinant human factor VII, long acting (Drug)
B
Experimental
干预措施: activated recombinant human factor VII, long acting (Drug)
结局指标
主要结局
Frequency of serious adverse events
时间窗: after 1, 2 and 6-10 weeks after dosing
Frequency of ocurrence of neutralising antibodies against FVII and/or LA-rFVIIa
时间窗: after 2 and 6-10 weeks after dosing
Frequency of adverse events
时间窗: after 1 and 2 weeks after dosing
Frequency of MESIs (Medical Event of Special Interest)
时间窗: after 1, 2 and 6-10 weeks after dosing
次要结局
- Pharmacokinetic parameters based on FVIIa activity. The pharmacokinetic parameters to be reported are: AUC(0-48h), AUC(0-t) and AUC, C10min, Vz, CL, and t½(from time of dosing up to 72 hours after the last dose)
研究者
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