NCT02994407已完成1 期
Safety, Tolerability, and Pharmacokinetics Study of Single and Multiple Subcutaneous Doses of Turoctocog Alfa Pegol 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
- 50
- 试验地点
- 1
- 主要终点
- Number of adverse events
研究概览
简要总结
The trial is conducted in Asia, Europe and North America. The aim of the study is to evaluate the safety of administration under the skin of turoctocog alfa pegol (SC N8-GP) in patients with severe haemophilia A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, age above or equal to 18 years at the time of signing informed consent,(part A).
- •Male, age above or equal to 12 years at the time of signing informed consent,(part B).
- •Diagnosis of congenital haemophilia A based on medical records (FVIII activity <1%).
- •History of more than 150 exposure days to any FVIII containing products.
排除标准
- •Previous participation in this trial. Participation is defined as signed informed consent.
- •(Patients who have completed part A are allowed to also participate in part B. If so, a separate informed consent covering part B must be signed.)
- •Immune compromised patients due to human immunodeficiency virus (HIV) infection (defined as viral load greater than or equal to 400.000 copies/mL and/or cluster of differentiation 4+ (CD4+) lymphocyte count less than or equal to 200/μL performed at screening or defined by medical records no older than 6 months)
- •Any history of FVIII inhibitors (defined by medical records within 8 years of randomisation)
- •Inhibitors to FVIII (greater than or equal to 0.6 Bethesda unit (BU)) at screening, measured by Nijmegen modified Bethesda method at central laboratory.
研究组 & 干预措施
N8-GP s.c.
Experimental
干预措施: turoctocog alfa pegol (Drug)
结局指标
主要结局
Number of adverse events
时间窗: Day 0-Day 28
Count and % of Adverse events
次要结局
- Cmax(0-144 hours)
- Incidence of FVIII inhibitors above or equal to 0.6 BU(Day 0-Day 28)
- tmax- time to maximal FVIII activity(0-144 hours)
- Cmin -the minimal FVIII activity(0-144 hours)
- Area under the activity time curve from 0 to infinity(0-144 hours)
- Area under the activity time curve from 0 to last(0-144 hours)
- Area under the activity time curve from 0 to t(0-144 hours)
- Css, max - the maximal FVIII activity at steady state(0-144 hours)
- Css - the mean FVIII activity at steady state(0-144 hours)
- Racc - accumulation ratio(0-144 hours)
- tmin - time to minimal FVIII activity(0-144 hours)
- Css, min - the minimum FVIII activity at steady state(0-144 hours)
- t½ - terminal half-life(0-144 hours)
- CL - total plasma clearance of drug after intravenous administration(0-144 hours)
- Change in Coagulation parameters, von Willebrand Factor(Day 0, day 7)
- Vz -apparent volume of distribution during terminal phase(0-144 hours)
- Vss - apparent volume of distribution during steady state(0-144 hours)
- MRT - mean residence time(0-144 hours)
- Injection site reactions(Day 0 - day 28)
- Number of treatment requiring bleeding episodes(Day 0 - day 120)
- Consumption of FVIII(Day 0 - day 120)
- Change in Coagulation parameters, fibrinogen(Day 0, day 7)
- Change in Coagulation parameters, antithrombin(Day 0, day 7)
- Change in Coagulation parameters, international normalised ratio(Day 0, day 7)
- Change in Coagulation parameters, activated partial thromboplastin time(Day 0, day 7)
研究者
研究点 (1)
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