NCT02483208已完成1 期
Single Dose, Open-label, Randomized, Crossover Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 18
- 主要终点
- AUC(0-tlast)
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics of BAY81-8973 and Advate 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/mm3
- •Abnormal renal function (serum creatinine >2 times the upper limit of the normal [ULN] range)
- •Active liver disease verified by medical history or persistently elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times the ULN or severe liver disease as evidenced by, but not limited to any of the following: International Normalized Ratio (INR) >1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.
研究组 & 干预措施
BAY81-8973
Experimental
BAY81-8973 infusion to analyze pharmacokinetics
干预措施: BAY81-8973 (Drug)
Advate
Other
Advate infusion to analyze pharmacokinetics.
干预措施: Advate (Drug)
结局指标
主要结局
AUC(0-tlast)
时间窗: Pre-Dose, 0.25, 0.5, 1, 3, 6, 8, 24, 30, 48 hours after treatment
Area under the blood concentration vs time curve from zero to the last data point \> lower limit of quantification
次要结局
未报告次要终点
研究者
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