A Canadian, Multi-center, Prospective, Open-label, Observational, Pharmacovigilance Study to Assess the Safety of Humate-P® Ivr (Infusion Volume Reduced) in Patients Transitioning From Treatment With Currently Available Humate-P®

CSL Behring0 个研究点目标入组 21 人开始时间: 2008年2月最近更新: 2011年2月11日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: CSL Behring
入组人数: 21
主要终点: To assess the safety and tolerability of Humate-P® (reported adverse events)

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

As part of CSL Behring Canada's continued commitment to ensuring the safety of the new low volume preparation of Humate-P®, CSL Behring Canada proposes to conduct a prospective, multi-center structured data collection of routine management of patients with von Willebrand disease treated with Humate P® ivr in Canada. The surveillance will be non-interventional and non-experimental. During the observation period, the routine medical care of the patient will be documented.

It is expected that there will be no difference in the safety and tolerability of Humate-P® ivr compared to Humate-P®

研究设计

研究类型: Observational
观察模型: Case Only
时间视角: Prospective

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Male or female patients of any age;
•Patients who are suffering with von Willebrand disease previously treated with Humate-P®;
•Patients who are able to communicate well with the Investigator and his/her representatives;
•Patients who are able and agreeing to comply with all study requirements;
•Patients who have provided written signed and dated informed consent prior to any study procedures being performed.

排除标准

•Patients who have received any investigational drug ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy.

结局指标

主要结局

To assess the safety and tolerability of Humate-P® (reported adverse events)

时间窗: 6 months

次要结局

To capture efficacy data on Humate-P® ivr: • supporting clinical management of bleeding episode or surgery • incidence of relevant bleeding episodes(6 months)

研究者

发起方

CSL Behring

申办方类型

Industry

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