EUCTR2015-005327-63-DK进行中（未招募）1 期
A multi-centre, comparative, double blind, randomised cross-over trial 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 - pathfinder™7
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. 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.
- •2. Ongoing participation in pathfinder™2 (NN7088-3859)
- •3. Male, age = 12 years at the time of signing informed consent (in certain countries the lower age limit will be 18 years, according to local requirements)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1. FVIII inhibitors (=0.6 BU) at last visit in pathfinder™2 prior to entry in pathfinder™7
- •2. Planned surgery during the trial
- •3. Major surgery performed within 4 weeks prior to screening
- •4. Previous participation in this trial. Participation is defined as signed informed consent
- •5. 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
研究者
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已完成
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A multi-centre, comparative, double blind, randomised cross-over trial 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 Ablood clotting disorderHaemophilia A10064477NL-OMON42941ovo Nordisk2
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