NCT01562587已完成1 期
Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non-Bleeding State
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
- 18
- 试验地点
- 1
- 主要终点
- Area under the concentration curve from 0-12 hours
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to determine the pharmacokinetics of activated recombinant human factor VII (NovoSeven®) in haemophiliac patients in a non-bleeding state.
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
- 3 Years 至 55 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 18-55 years and congenital haemophilia A or B male with severe FVIII or FX deficiency +/-inhibitors
- •Age between 3-12 years and congenital haemophilia A or B male with record of inhibitors
排除标准
- •Known hypersensitivity to activated recombinant human factor VII or any of its components
- •Known clinical relevant coagulation diseases or insufficiencies other than congenital haemophilia
- •Clinical manifestation of HIV (human immunodeficiency virus) and/or protease inhibitor treatment
- •Clinical manifestation of active/recent bleeding
- •Administration of coagulation factor preparations within 24 hours of NovoSeven trial product dose administration
- •Body Mass Index (BMI) outside normal range
- •Known abuse of elicit drugs and/or alcohol
- •Renal insufficiency
- •Hepatic disease
- •Cardiovascular disease
- •Any disease or condition which, judged by the Investigator, could imply a potential hazard to the patient, interfere with the trial participation or trial outcome
研究组 & 干预措施
Adults
Experimental
干预措施: activated recombinant human factor VII (Drug)
Paediatric
Experimental
干预措施: activated recombinant human factor VII (Drug)
结局指标
主要结局
Area under the concentration curve from 0-12 hours
次要结局
- CL, the total body clearance
- t1/2, the terminal half-life
- Cmax, the maximum concentration
- tmax, the time to maximum concentration
- Area under the concentration curve from time 0-infinity
- Vss, the apparent volume of distribution at steady state
- Adverse events
研究者
研究点 (1)
Loading locations...
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