A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID)
- Conditions
- Patients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 yearsMedDRA version: 8.1Level: LLTClassification code 10010112Term: Common variable immunodeficiency
- Registration Number
- EUCTR2006-006522-25-BE
- Lead Sponsor
- CSL Behring AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 28
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 Women who have become pregnant during the course of the study have to be withdrawn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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method