EUCTR2006-006522-25-IT
Active, not recruiting
Not Applicable
A Multicenter study on the efficacy and safety of Vivaglobin in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID) - ND
ConditionsPatients 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
DrugsVivaglobin
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 years.
- Sponsor
- CSL Behring AG
- Enrollment
- 28
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 Women who have become pregnant during the course of the study have to be withdrawn 9\.Participation in a study with an investigational product within 3 months prior to enrollment 10\.Known or suspected HIV infection, acute hepatitis or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
Outcomes
Primary Outcomes
Not specified
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