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

• Conditions: Patients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 years.; MedDRA version: 6.1Level: PTClassification code 10057863

• Registration Number: EUCTR2006-006522-25-IT
• Lead Sponsor: CSL Behring AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1.Written informed consent, age-adapted Male or female ages 1 to 70 years 2.Diagnosis of primary immunodeficiency (CVID as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies) XLA) 3.No prior immunoglobulin treatment 4.IgG level of <500 mg/dL at screening 5.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

Exclusion Criteria

1.Evidence of serious infection between screening and Day 1 (day of first Vivaglobin infusion) 2.Bleeding disorders that require 4.Hypoalbuminemia, protein-losing enteropathies, and nephropathy with proteinuria 5.Lymphoprolipherative disease (i.e. lymphoma) 6.Evidence for bronchiectasis 7.Known allergic reaction to blood products 8.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 Women who have become pregnant during the course of the study have to be withdrawn 9.Participation in a study with an investigational product within 3 months prior to enrollment 10.Known or suspected HIV infection, acute hepatitis or clinically active chronic hepatitis 11.ASAT or ALAT concentration > 2.5 times the UNL Creatinine concentration > 1.5 times the UNL 12.Any condition that is likely to interfere with evaluation of the study drug or satisfactory conduct of the trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified