临床试验/NCT02941354

NCT02941354已完成1 期

A Multicentre, Open-label Trial Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 35 人开始时间: 2016年10月10日最近更新: 2019年1月30日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 35
试验地点: 1
主要终点: Plasma FVIII activity at 30 minutes(C30min)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This trial is conducted globally. The aim of this trial is evaluating the pharmacokinetics (the exposure of the trial drug in the body) of NovoEight® (turoctocog alfa) in relation to BMI (body mass index) in subjects with 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: 18 Years 至 —（Adult, Older Adult）
性别: Male
接受健康志愿者: 否

入选标准

•Male, age at least 18 years at the time of signing informed consent
•History of more than 150 exposure days to any factor VIII products
•Subjects with the diagnosis of congenital haemophilia A with factor VIII activity below 1%, based on medical records

排除标准

•Known history of factor VIII inhibitors
•Inhibitors to factor VIII (above or equal to 0.6 BU (Bethesda units)) at screening measured by the Nijmegen modified Bethesda method
•Known congenital or acquired coagulation disorders other than haemophilia A
•Previous participation in pharmacokinetic sessions with turoctocog alfa in another trial

研究组 & 干预措施

Turoctocog alfa

Experimental

干预措施: turoctocog alfa (Drug)

结局指标

主要结局

Plasma FVIII activity at 30 minutes(C30min)

时间窗: At 30 minutes post-dose

Based on samples taken at pre-dose (-1hour), 15minutes, 30minutes, 1hour, 3hours, 6hours, 9hours, 24hours, 28hours, 48hours, 72hours post-dose

次要结局

Area under the FVIII activity-time curve(From 0 up to 72 hours after administration)
Incremental recovery FVIII at 30 minutes (IR30min)(At 30 minutes post-dose)
Terminal half-life (t½) of FVIII(From 0 up to 72 hours after administration)
Clearance (CL) of FVIII(From 0 up to 72 hours after administration)
Apparent volume of distribution at steady state (Vss) of FVIII(From 0 up to 72 hours after administration)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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