NCT03075670已完成1 期
A Trial Comparing the Pharmacokinetics of Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B
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
- 15
- 试验地点
- 1
- 主要终点
- Area under the factor IX activity-time curve from 0 to infinity dose-normalised to 50 IU/kg
研究概览
简要总结
This trial is conducted in Europe and the United States of America. The aim of this trial is to compare the pharmacokinetics (the exposure of the trial drug in the body) of nonacog beta pegol (N9-GP) and ALPROLIX® in patients with haemophilia B.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, aged 18-70 years (both inclusive) at the time of signing informed consent
- •Patients with the diagnosis of congenital haemophilia B with factor IX activity below or equal to 2%, based on medical records
- •History of more than 150 exposures days to any factor IX containing products
排除标准
- •Known history of factor IX inhibitors
- •Inhibitors to factor IX (above or equal to 0.6 BU) at screening measured by the Nijmegen modified Bethesda method
- •Immunocompromised (CD4+ T cells below or equal to 200/μL)
- •Known congenital or acquired coagulation disorders other than haemophilia B
- •Body mass index above 35 kg/m^²
研究组 & 干预措施
N9-GP
Experimental
干预措施: N9-GP (Drug)
ALPROLIX®
Active Comparator
干预措施: ALPROLIX® (Drug)
结局指标
主要结局
Area under the factor IX activity-time curve from 0 to infinity dose-normalised to 50 IU/kg
时间窗: From time 0 (dosing) up to 240 hours post-dose
Calculated based on plasma FIX activity measured in blood
次要结局
- Maximum activity dose-normalised to 50 IU/kg (Cmax,norm)(From time 0 (dosing) up to 240 hours post-dose)
- Incremental recovery at 30 minutes (IR30min)(At 30 minutes)
- Activity at 168 hours (C168h)(At 168 hours)
- Mean residence time (MRT)(From time 0 (dosing) up to 240 hours post-dose)
- Terminal elimination rate constant(From time 0 (dosing) up to 240 hours post-dose)
- Area under the activity-time curve from 0 to infinity(From time 0 (dosing) up to 240 hours post-dose)
- Number of adverse events(From time 0 (dosing) up to 240 hours post-dose)
- Terminal half-life (t½)(From time 0 (dosing) up to 240 hours post-dose)
- Clearance (CL)(From time 0 (dosing) up to 240 hours post-dose)
- Area under the activity-time curve(From time 0 (dosing) up to 240 hours post-dose)
- Maximum activity (Cmax)(From time 0 (dosing) up to 240 hours post-dose)
- Activity at 30 minutes (C30min)(at 30 minutes)
- Incremental recovery at maximum activity (IRCmax)(From time 0 (dosing) up to 240 hours post-dose)
- Apparent volume of distribution at steady-state (Vss)(From time 0 (dosing) up to 240 hours post-dose)
- Time of maximum activity (tmax)(From time 0 (dosing) up to 240 hours post-dose)
- Apparent volume of distribution during terminal phase (Vz)(From time 0 (dosing) up to 240 hours post-dose)
- Area under the activity-time curve from 0 to t last(From time 0 (dosing) up to 240 hours post-dose)
研究者
研究点 (1)
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