NCT02250508已完成2 期
A Randomised, Comparative, Single Dose, Open Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Different Types of Von Willebrand Disease.
Bio Products Laboratory1 个研究点 分布在 1 个国家开始时间: 2004年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 1
- 主要终点
- AUC (0-48h) for VWF: RCo
研究概览
简要总结
The main objectives of the study were
- to compare the pharmacokinetics (PK) of Optivate® and Haemate P® in various types of vonWillebrand disease (VWD) using the results from the VWF: RCo, VWF:Ag, VWF:CBA and Factor VIII assays.
- to compare the clinical tolerance and safety of these two treatments after single IV infusions in subjects with VWD.
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
- •Previously treated subjects of at least 12 years of age, with any type of VWD were eligible for entry into this study.
排除标准
- 未提供
研究组 & 干预措施
Haemate P®
Active Comparator
干预措施: Haemate P® (Human Coagulation Factor VIII) (Biological)
Optivate®
Experimental
干预措施: Optivate® (Human Coagulation Factor VIII) (Biological)
结局指标
主要结局
AUC (0-48h) for VWF: RCo
时间窗: Pre-dose, 30 min, 1, 2, 5, 8, 24, 48 hours post-dose
次要结局
未报告次要终点
研究者
研究点 (1)
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