EUCTR2010-023070-40-GB进行中（未招募）不适用
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 - paradigm™3
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 16
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
- •Patients with haemophilia B, aged 13-70 years and with a FIX activity of =2%.
- •Male patients with moderately severe or severe congenital haemophilia B with a FIX activity =2% according to medical records
- •History of at least 150 exposure days to other FIX products
- •Scheduled major surgery
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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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