An Open Label Multi-center Study to Assess the Efficacy and Safety of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery

Wyeth is now a wholly owned subsidiary of Pfizer17 个研究点分布在 8 个国家目标入组 30 人开始时间: 2006年4月1日最近更新: 2011年6月3日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 30
试验地点: 17
主要终点: Number of Patients Who Achieved Hemostatic Efficacy After Surgery

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will examine the efficacy and safety of ReFacto AF in patients with severe and moderately severe hemophilia A undergoing elective major surgery when administered by either bolus injections (BI) or continuous infusion (CI).

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 12 Years 至 —（Child, Adult, Older Adult）
性别: Male
接受健康志愿者: 否

入选标准

•Male, at least 12 years old, with severe hemophilia A undergoing major elective major surgery requiring FVIII replacement for at least 6 days. Negative FVIII inhibitor test at screening and no past history of inhibitor.
•Previously treated with at least 150 exposure days to any Factor VIII product
•Normal hepatic and renal function tests and no other bleeding disorder

排除标准

未提供

结局指标

主要结局

Number of Patients Who Achieved Hemostatic Efficacy After Surgery

时间窗: 6 weeks

Efficacy at the end of surgery as determined by the investigator and/or the surgeon using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients.

次要结局

Number of Patients Who Achieved Hemostatic Efficacy at Hospital Discharge(6 weeks)

研究者

发起方

Wyeth is now a wholly owned subsidiary of Pfizer

申办方类型

Industry

研究点 (17)

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