NCT00168090已完成4 期
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.
适应症
相关药物
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
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
研究点 (1)
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