Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjects With Von Willebrand's Disease.

CSL Behring1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2001年10月1日最近更新: 2011年2月11日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: CSL Behring
入组人数: 30
试验地点: 1
主要终点: To demonstrate the efficacy and safety of HumateP® in preventing excessive bleeding in pediatric and adult surgical subjects with vWD using individualized dosing based on VWF:RCo and FVIII:C monitoring.

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

The purpose of this study is to test the safety and effectiveness of Humate-P® to prevent bleeding in patients with von Willebrand Disease who are undergoing surgery.

研究设计

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

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Subjects of any age
•Clinical and laboratory diagnosis of vWD that can be expected to show no hemostatic response to DDAVP
•Require substitution with vWF/FVIII complex due to a surgery

排除标准

•Known significant hemostatic disorder other than vWD
•Acquired vWD
•Known antibodies to FVIII or vWF
•Known platelet type vWD
•Emergency surgery or any surgery with a degree of urgency not permitting completion of a pharmacokinetic assessment required by the study protocol
•History of allergic reaction to Humate-P®
•Treatment with any other investigational drug in the last four weeks before the entry into the study (with exception of trials concerning anti-HIV agents)
•Progressive fatal disease/life expectancy of less than 6 months
•Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives containing substantial quantities of FVIII and/or vWF within 5 days of the pre-surgical pharmacokinetic assessment
•Pediatric patients of insufficient body weight to permit PK sampling
•Woman in the first 20 weeks of pregnancy

结局指标

主要结局

To demonstrate the efficacy and safety of HumateP® in preventing excessive bleeding in pediatric and adult surgical subjects with vWD using individualized dosing based on VWF:RCo and FVIII:C monitoring.

次要结局

To document the pharmacokinetics of Humate-P® in pediatric and adult subjects with various types of vWD.

研究者

发起方

CSL Behring

申办方类型

Industry

研究点 (1)

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