Multi-centre, Open-labelled Trial Investigating the Pharmacokinetics of Four Lots of Turoctocog Alfa in Subjects With Haemophilia A
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
- Dose normalised area under the curve (AUC/actual dose) based on chromogenic assay
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) of four lots of turoctocog alfa (a human recombinant coagulation factor VIII (FVIII)) in subjects with haemophilia A.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- •Male subjects with the diagnosis of severe haemophilia A (FVIII<1%) from age 18 years
- •Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds)
- •Immunocompetent (HIV (Human Immunodeficiency Virus) positive subjects should have CD4+ (Cluster of differentiation 4; a glycoprotein expressed on the surface) lymphocyte count >200/microL)
排除标准
- •Detectable inhibitors to FVIII (above or equal to 0.6 Bethesda Units (BU))
- •History of FVIII inhibitors
- •Severe current hepatic dysfunction or severe hepatic disease during the last 12 months
- •Known or suspected allergy to trial product (FVIII) or related products
- •Subjects receiving immune modulating medication or immune tolerance induction (ITI) regimens
- •Body mass index (BMI) above 30 kg/m^2
研究组 & 干预措施
Lot A
Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.
干预措施: turoctocog alfa (Drug)
Lot B
Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.
干预措施: turoctocog alfa (Drug)
Lot C
Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.
干预措施: turoctocog alfa (Drug)
Lot D
Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.
干预措施: turoctocog alfa (Drug)
结局指标
主要结局
Dose normalised area under the curve (AUC/actual dose) based on chromogenic assay
时间窗: up to 48 hours after i.v. administration
次要结局
- Dose normalised area under the FVIII activity-time curve (AUC/actual dose) based on one stage clot assay(up to 48 hours after i.v. administration)
- Clearance of FVIII (CL)(up to 48 hours after i.v. administration)
- Incidence of adverse events (AEs) including FVIII inhibitors(After approximately 3 months (at end of trial))
- Incremental recovery (IR30min) (defined as the peak FVIII level recorded 30 min after injection and reported as[IU/mL]/[IU/kg])(up to 48 hours after i.v. administration)
- Terminal half-life of FVIII (t½)(up to 48 hours after i.v. administration)
- Area under the FVIII activity-time curve (AUC)(up to 48 hours after i.v. administration)