EUCTR2015-005327-63-FR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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