Single Dose, Open Label, Randomized, Crossover Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters of BAY 94 9027 and Elocta
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- AUC from time 0 to the last data point
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics of BAY94-9027 and Elocta after intravenous administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males, age 18 to 65 years.
- •Subjects with Severe Hemophilia A with a documented plasma FVIII level of < 1%
- •≥ 150 exposure days with FVIII concentrate(s) as supported by medical records
排除标准
- •Evidence of current or past inhibitor antibody:
- •History of any congenital or acquired coagulation disorders other than hemophilia A.
- •Platelet count <75,000/mm*
- •Abnormal renal function (serum creatinine >2 x the upper limit of the normal range).
- •Active liver disease verified by medical history or persistently elevated alanine aminotransferase or aspartate aminotransferase >5 x the upper limit of the normal range or severe liver disease as evidenced by, but not limited to any of the following: International Normalized Ratio >1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.
研究组 & 干预措施
BAY94-9027 and Elocta
Subjects received two treatments: 60 IU/kg BAY94-9027 in the first period, followed by 60 IU/kg Elocta in the second period, with a washout period before each treatment
干预措施: Damoctocog (Jivi, BAY94-9027) (Drug)
BAY94-9027 and Elocta
Subjects received two treatments: 60 IU/kg BAY94-9027 in the first period, followed by 60 IU/kg Elocta in the second period, with a washout period before each treatment
干预措施: Elocta (Drug)
Elocta and BAY94-9027
Subjects received two treatments: 60 IU/kg Elocta in the first period, followed by 60 IU/kg BAY94-9027 in the second period, with a washout period before each treatment
干预措施: Damoctocog (Jivi, BAY94-9027) (Drug)
Elocta and BAY94-9027
Subjects received two treatments: 60 IU/kg Elocta in the first period, followed by 60 IU/kg BAY94-9027 in the second period, with a washout period before each treatment
干预措施: Elocta (Drug)
结局指标
主要结局
AUC from time 0 to the last data point
时间窗: Pre-Dose and up to 120 hours post dose
Area under the concentration time profile curve.
次要结局
未报告次要终点