An Open Study to Evaluate the Safety and Efficacy of IVIG-F10 in Patients With Primary Immunodeficiency Diseases (PID)

CSL Behring0 个研究点目标入组 42 人开始时间: 2004年9月最近更新: 2011年2月11日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: CSL Behring
入组人数: 42
主要终点: Proportion of infusions temporally (during the infusion and within 48 hours after the end of infusion) associated with one or more adverse events, regardless of relationship.

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

The purpose of this study is to demonstrate the effect of IVIG-F10 on the prevention of serious bacterial infections in patients with primary immunodeficiency.

As secondary endpoints the rate of overall infections, the tolerability and safety of IVIG-F10 are studied.

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

年龄范围: 3 Years 至 70 Years（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients with primary immunodeficiency
•Regular IVIG therapy for at least 6 months prior to receiving IVIG-F10

排除标准

•Allergic reactions to immunoglobulins or other blood products
•Steroids (oral and parenteral, daily ≥0.15 mg of prednisone equivalent/kg/day
•History of cardiac insufficiency
•Epilepsia

结局指标

主要结局

Proportion of infusions temporally (during the infusion and within 48 hours after the end of infusion) associated with one or more adverse events, regardless of relationship.

次要结局

Rate, severity and relationship of all adverse events
Rate of acute serious bacterial infections
Number of days out of work/school due to underlying PID
Number of infections

研究者

发起方

CSL Behring

申办方类型

Industry

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