NCT01205724已完成1 期
A Multi-National, Open-Label, Dose Escalation Trial, Evaluating Safety and Pharmacokinetics of Intravenous Doses of NNC 0129-0000-1003 in Patients With Haemophilia A
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Frequency of adverse events (AEs) reported after administration of trial product
研究概览
简要总结
This trial is conducted globally. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the determination of the concentration of the administered medication in blood over time) of NNC 0129-0000-1003 in previously treated subjects with severe haemophilia A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Haemophilia A
- •Body Mass Index (BMI) below 35 kg/m2
- •History of a minimum 150 exposure days (EDs) to FVIII products (prophylaxis/prevention/surgery/on-demand)
排除标准
- •Any history of FVIII inhibitors
- •Surgery planned to occur during the trial
- •Platelet count less than 50,000 platelets/microlitre (assessed by laboratory)
- •Congenital or acquired coagulation disorders other than haemophilia A
研究组 & 干预措施
A
Experimental
干预措施: turoctocog alfa pegol (Drug)
B
Experimental
干预措施: turoctocog alfa pegol (Drug)
C
Experimental
干预措施: turoctocog alfa pegol (Drug)
结局指标
主要结局
Frequency of adverse events (AEs) reported after administration of trial product
时间窗: up to four weeks after trial product administration
次要结局
- Area under the curve (AUC), total clearance (CL), terminal half-life (T½), incremental recovery (first sample)(from 0 to 168 hours after trial product administration)
- Safety assessment including physical examination, vital signs, electrocardiogram (ECG) and clinical laboratory assessments(up to four weeks after trial product administration)
研究者
研究点 (1)
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