EUCTR2006-006522-25-GR
Active, not recruiting
Phase 1
A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID)
ConditionsPatients 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
DrugsVivaglobin
Overview
- Phase
- Phase 1
- 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
- 18
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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 Women who have become pregnant during the course of the study have to be withdrawn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·
Outcomes
Primary Outcomes
Not specified
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