NCT02920398已完成1 期
This Trial is Conducted in Europe and the United States of America. The Aim of This Trial is to Investigate Single Dose Pharmacokinetics (the Exposure of the Trial Drug in the Body) and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A.
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
- 21
- 试验地点
- 1
- 主要终点
- Area under the FVIII activity-time curve
研究概览
简要总结
Investigating single dose pharmacokinetics and safety of turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process in patients with severe haemophilia A
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, 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
- •Ongoing participation in pathfinder™2
- •Male, age at least 12 years at the time of signing informed consent (in certain countries the lower age limit will be 18 years, according to local requirements)
排除标准
- •FVIII inhibitors (≥0.6 BU) at last visit in pathfinder™2 prior to entry in pathfinder™7
- •Planned surgery during the trial
- •Major surgery performed within 4 weeks prior to screening
- •Previous participation in this trial. Participation is defined as signed informed consent
- •Any disorder, except for conditions associated with haemophilia A, which in the investigator's opinion might jeopardise patient's safety or compliance with the protocol
研究组 & 干预措施
N8-GP commercial
Active Comparator
干预措施: turoctocog alfa pegol (Drug)
N8-GP pivotal
Experimental
干预措施: turoctocog alfa pegol (Drug)
结局指标
主要结局
Area under the FVIII activity-time curve
时间窗: From 0 to 96 hours post injection
次要结局
- Clearance in blood plasma of FVIII activity(From time of trial product administration to 96 hours post-dose)
- Terminal half-life(From time of trial product administration to 96 hours post-dose)
- Area under the FVIII activity-time curve from 0 to infinity(From time of trial product administration to 96 hours post-dose)
- Incremental recovery in blood plasma of FVIII activity(From time of trial product administration to 96 hours post-dose)
- FVIII activity 30 min post administration - dose normalised to 50 U/kg(From time of trial product administration to 96 hours post-dose)
研究者
研究点 (1)
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