NL-OMON36798撤回3 期
An Open-label, Multi-centre, Un-controlled Trial to Assess Efficacy and Safety of NNC-0156-0000-0009 during Surgical Procedures in Patients with Haemophilia B - Paradigm3
ovo Nordisk0 个研究点目标入组 2 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 2
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 patients, aged 13-70 years, with moderately severe or severe congenital haemophilia B with a FIX activity <=2% according to medical records
- •NB: In The Netherlands only patients aged 18-70 years will be included
- •History of at least 150 exposure days to other FIX products
- •Scheduled major surgery
排除标准
- •Known history of FIX inhibitors based on existing medical records, laboratory report reviews and patient and LAR interviews
- •Current FIX inhibitors >=0.6 BU (central laboratory)
- •Previous arterial thrombotic events (e.g. myocardial infarction and intracranial thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by available medical records)
- •ALT >3 times the upper limit of normal reference ranges at screening (central laboratory)
- •Immune modulating or chemotherapeutic medication
研究者
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