NCT01365520已完成1 期
Multi-Centre, Open-Label, Randomised Trial Investigating the Pharmacokinetics of a Single Dose of NNC 0155-0000-0004 (N8) 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
- 4
- 试验地点
- 1
- 主要终点
- Area under the curve
研究概览
简要总结
This trial is conducted in Asia and Europe. The aim of the trial is to investigate the pharmacokinetics (the rate at which the trial drug is eliminated from the body) of a single dose of turoctocog alfa (NNC 0155-0000-0004 (N8)) in patients with haemophilia A. Participation in this trial is dependent on previous participation in trial NN7008-3543 (Part B) (NCT00840086).
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
- None
入排标准
- 年龄范围
- 12 Years 至 56 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects with the diagnosis of severe haemophilia A (factor VIII less than or equal to 1%)
- •Body weight between 10 to 120 kg
- •Subjects who have completed NN7008-3543 (Part B) or subjects participating in NN7008-3568 after completion of NN7008-3543 (NCT00840086)
排除标准
- •Known or suspected hypersensitivity to trial product(s) or related products
- •Previous participation in this trial defined as withdrawal
- •Planned surgery during the trial period (catheter, stents, ports, and dental extractions do not count as surgeries and will not exclude the subject)
- •Any disease or condition which, according to the trial physician's judgement, could imply a potential hazard to the subject, interfere with the trial participation or trial outcome
研究组 & 干预措施
N8
Experimental
干预措施: turoctocog alfa (Drug)
结局指标
主要结局
Area under the curve
时间窗: Infusion, 48 hours
In vivo t1/2
时间窗: Infusion, 48 hours
Total clearance (CL)
时间窗: Infusion, 48 hours
Incremental recovery
时间窗: Infusion, 30 minutes
次要结局
- Number of adverse events(up to 48 hours after trial drug administration)
- Maximal concentration (Cmax)(15 minutes after trial drug administration)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Intra-subject Variability Following Administrations of Activated Recombinant Human Factor VII in Haemophilia Patients in a Non-bleeding StateCongenital Bleeding DisorderHaemophilia AHaemophilia BNCT01562457Novo Nordisk A/S30
已完成
2 期
Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Allogeneic Stem Cell TransplantationAcquired Bleeding DisorderBleeding During/Following SurgeryNCT01562158Novo Nordisk A/S100
已完成
3 期
Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725Congenital Bleeding DisorderCongenital FXIII DeficiencyNCT00978380Novo Nordisk A/S63
已完成
1 期
Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A SubjectsCongenital Bleeding DisorderHaemophilia ANCT00837356Novo Nordisk A/S23
已完成
3 期
A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone DeficiencyAdult Growth Hormone DeficiencyGrowth Hormone DisorderNCT02382939Novo Nordisk A/S92