A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID)

CSL Behring AG0 个研究点目标入组 28 人开始时间: 2006年12月7日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Written informed consent, age-adapted·Male or female ages 1 to 70 years
•Diagnosis of primary immunodeficiency oCVID as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies)oXLA
•No prior immunoglobulin treatment
•IgG level of <500 mg/dL at screening
•Women of childbearing potential must use medically approved contraception and must have a negative urine pregnancy test at screening
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Evidence of serious infection between screening and Day 1 (day of first Vivaglobin infusion)
•Bleeding disorders that require medical treatments (e.g. hemophilia)
•Any medical disorder causing secondary immune disorders, autoimmune neutropenia, or a clinically significant defect in cell mediated immunity
•Hypoalbuminemia, protein-losing enteropathies, and nephropathy with proteinuria·Lymphoprolipherative disease (i.e. lymphoma)
•Evidence for bronchiectasis
•Known allergic reaction to blood products
•Pregnant or breast-feeding females or females planning to become pregnant during the course of the study. Women who have become pregnant during the course of the study have to be withdrawn
•Participation in a study with an investigational product within 3 months prior to enrollment
•Known or suspected HIV infection, acute hepatitis or clinically active chronic hepatitis
•ASAT or ALAT concentration > 2.5 times the UNL·
•Creatinine concentration > 1.5 times the UNL
•Any condition that is likely to interfere with evaluation of the study drug or satisfactory conduct of the trial

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