NCT00037544已完成3 期
An Open-Label Study to Characterize the Safety and Efficacy of BDDrFVIII Manufactured by the Albumin Free Process (ReFacto AF) in the Treatment of Previously Treated Patients (PTP) With Severe Hemophilia A
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点开始时间: 2002年5月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
To characterize the safety and efficacy of ReFacto AF in treating acute bleeding episodes during prophylaxis treatment, including neoantigenicity.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe hemophilia A (FVIII:C less than or equal to 2% at local laboratory)
- •Previously treated patients with greater than or equal to 250 exposure days to any Factor VIII product
- •Age greater than or equal to 12 years
- •History of prophylaxis dosing at least twice per week on any Factor VIII product for at least 3 consecutive months within the 2 years prior to study enrollment unless the patient completed the previous pharmacokinetic study
- •Adequate laboratory results
排除标准
- •Presence of any bleeding disorder in addition to hemophilia A
- •Concomitant therapy with immunosuppressive drugs
- •Current or historical Factor VIII inhibitor
- •Treatment with any investigational drug or device within the past 30 days
研究者
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