NL-OMON42365撤回不适用
A multi-centre, randomised, placebo controlled, double blinded, multiple dose trial investigating safety, pharmacokinetics and pharmacodynamics of concizumab administered subcutaneously to haemophilia A subjects - explorerTM3
ovo Nordisk0 个研究点目标入组 3 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Male subjects diagnosed with haemophilia A without inhibitors present at screening and currently treated on-demand.
- •- Subjects with a baseline level of factor VIII * 2 % based on medical records.
- •- Age between 18 and 64 years both inclusive, at the time of signing informed consent
- •- Body weight between 50 and 100 kg, both inclusive.
排除标准
- •- Known or suspected hypersensitivity to trial product or related products.
- •- Platelet count below 50x10^9/L at screening.
- •- Any clinical signs or known history of thromboembolic events, or subjects considered at high risk of thromboembolic events as judged by the investigator.
- •- Subjects at increased risk of cardiovascular disease as judged by the investigator.
研究者
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