NCT00168051撤回4 期
A Single Dose, Randomized, 2-Period Crossover Study in Patients With Hemophilia A to Evaluate the Pharmacokinetics of ReFacto (B-domain Deleted Recombinant Human Factor VIII (BDDrFVIII) and Advante (a Full-length Recombinant Factor VIII (FLrFVIII)
Wyeth is now a wholly owned subsidiary of Pfizer13 个研究点 分布在 8 个国家开始时间: 2005年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 13
- 主要终点
- Pharmacokinetic measurement of area under the plasma Factor VIII activity in plasma versus time curve for 48 hours.
研究概览
简要总结
The purpose of the study is to compare the pharmacokinetic parameters of ReFacto and Advate, using the chromogenetic substrate assay to measure plasma Factor VIII activity in plasma.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Severe hemophilia A
- •Previously treated patients with at least 150 exposure days to any Factor VIII product
排除标准
- •Hypersensitivity to any recombinant Factor VIII product
- •History of or current Factor VIII inhibitor
- •Bleeding episode or other reason requiring Factor VIII treatment within 3 days of study
结局指标
主要结局
Pharmacokinetic measurement of area under the plasma Factor VIII activity in plasma versus time curve for 48 hours.
次要结局
- Number of subjects who experience any adverse event or develop Factor VIII inhibitor at study termination, 48 hours post dosing and/or at the final study visit within seven days of the 2nd period of the study.
研究者
研究点 (13)
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