临床试验/NCT00168025

NCT00168025已完成3 期

A Multicenter Study on the Efficacy, Safety and Pharmacokinetics of IgPro10 in Patients With Primary Immunodeficiency (PID)

CSL Behring0 个研究点目标入组 89 人开始时间: 2004年9月最近更新: 2012年6月6日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: CSL Behring
入组人数: 89
主要终点: Annualized rate of acute serious bacterial infections

研究概览研究设计入排标准研究组 & 干预措施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 IgPro10 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 IgPro10 are studied.

A part of the patients are participating in a pharmacokinetic substudy.

研究设计

研究类型: Interventional
分配方式: Na
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
•Patients who have received stable IVIG therapy at 3- or 4-weekly intervals for at least 6 months

排除标准

•Newly diagnosed PID
•Allergic reactions to immunoglobulins or other blood products
•Administration of steroids (daily ≥ 0.15 mg prednisone equivalent/kg/day) or other immunosuppressive drugs
•Concomitant diseases such as hypoalbuminemia, protein-losing enteropathies, kidney diseases with proteinuria, malignancies of lymphoid cells (e.g. lymphocytic leukemia), and recent history of migraine
•History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension

研究组 & 干预措施

IgPro10

Experimental

干预措施: Immunoglobulins Intravenous (Human) (Drug)

结局指标

主要结局

Annualized rate of acute serious bacterial infections

次要结局

Number of infections
Number of days out of work / school due to underlying PID
Adverse events temporally associated with study drug infusion
Trough levels of total IgG serum concentrations

研究者

发起方

CSL Behring

申办方类型

Industry

责任方

Sponsor

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