NCT01333111已完成3 期
A Multi-centre, Single-blind Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC-0156-0000-0009 When Used for Treatment and Prophylaxis of Bleeding Episodes in Patients With Haemophilia B
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units)
研究概览
简要总结
This trial is conducted in Africa, Asia, Europe, Japan and North America. The aim of this trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at which the body eliminates the trial drug), of NNC-0156-0000-0009 (nonacog beta pegol) when used for treatment and prophylaxis of bleeding episodes in patients with haemophilia B.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 13 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients with moderately severe or severe congenital haemophilia B with a factor IX activity of 2% or below according to medical records
- •History of at least 150 exposure days to other factor IX products
- •Patients currently treated on-demand with at least 6 bleeding episodes during the last 12 months or at least 3 bleeding episodes during the last 6 months, or patients currently on prophylaxis
排除标准
- •Known history of factor IX inhibitors based on existing medical records, laboratory report reviews and patient and legally acceptable representative (LAR) interviews
- •HIV (Human immunodeficiency virus) positive, with a viral load equal to or above 400,000 copies/mL and/or CD4+ lymphocyte count equal to or below 200/microL
- •Congenital or acquired coagulation disorders other than haemophilia B
- •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)
- •Immune modulating or chemotherapeutic medication
研究组 & 干预措施
Prophylaxis, high dose (trial duration 52 weeks)
Experimental
干预措施: nonacog beta pegol (Drug)
Prophylaxis, low dose (trial duration 52 weeks)
Experimental
干预措施: nonacog beta pegol (Drug)
On-demand (trial duration 28 weeks)
Experimental
干预措施: nonacog beta pegol (Drug)
结局指标
主要结局
Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units)
时间窗: 28 weeks after treatment start on on-demand treatment
Inhibitors were analysed with either the Nijmegen modified factor IX Bethesda assay or a heat/cold Nijmegen modified factor IX Bethesda assay. Number of subjects who developed inhibitory antibodies against factor IX are reported.
次要结局
- Haemostatic Effect of NNC-0156-0000-0009 When Used for Prophylaxis of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response(52 weeks after treatment start for patients on prophylaxis)
- Haemostatic Effect of NNC-0156-0000-0009 When Used for Treatment of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response(28 weeks after treatment start on on-demand treatment)
- Number of Bleeding Episodes Per Patient During Routine Prophylaxis(52 weeks after treatment start for patients on prophylaxis)
- Factor IX Trough Levels(52 weeks after treatment start for patients on prophylaxis)
- Incidence of Serious Adverse Events (SAEs)(at 32 weeks ±2 weeks for patients on on-demand treatment)
- Host Cell Proteins (HCP) Antibodies(28 weeks after treatment start on on-demand treatment)
- Incidence of Adverse Events (AEs)(at 32 weeks ±2 weeks for patients on on-demand treatment)
研究者
研究点 (1)
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