NCT01653639已完成1 期
Single Dose, Open-label, Randomized, Crossover Study in Subjects With Severe Hemophilia A to Compare the Bioavailability of 2 Different Strengths of Kogenate FS (BAY14-2222)
适应症
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
- Area under the plasma concentration vs time curve from time 0 to time of last measurable concentration AUC(0-tlast) of BAY14-2222
研究概览
简要总结
This is a single dose, open-label, randomized, crossover study in subjects with severe Hemophilia A to compare the bioavailability of 2 different strengths of Kogenate FS (BAY 14-2222).
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 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 ED (exposure days) with FVIII concentrates(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 range)
- •Active liver disease verified by medical history or persistently elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5x the upper limit of normal 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
结局指标
主要结局
Area under the plasma concentration vs time curve from time 0 to time of last measurable concentration AUC(0-tlast) of BAY14-2222
时间窗: Up to 48 hours
Maximum plasma concentration (Cmax) of BAY14-2222
时间窗: Up to 48 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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