EUCTR2010-023070-40-ES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
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: 2
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 6
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
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
相似试验
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 BHaemophilia BMedDRA version: 15.1Level: LLTClassification code 10018939Term: Haemophilia B (Factor IX)System Organ Class: 100000004850EUCTR2010-023070-40-ATovo Nordisk A/S16
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 Bblood clotting disorderHaemophilia B10064477NL-OMON36798ovo Nordisk2
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 3EUCTR2010-023070-40-ITOVO NORDISK16
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™3EUCTR2010-023070-40-NLovo Nordisk A/S16
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™3Haemophilia BMedDRA version: 14.1Level: LLTClassification code 10018939Term: Haemophilia B (Factor IX)System Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2010-023070-40-GBovo Nordisk A/S16