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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 18

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
F.1.3.1 Number of subjects for this age range

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 Women who have become pregnant during the course of the study have to be withdrawn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·
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
Main Objective: The study is designed to assess the efficacy and safety of Vivaglobin in patients with PID who have not received prior immunoglobulin treatment;Secondary Objective: ;Primary end point(s): The primary objective of this trial is to show an increase in the total serum IgG trough level to = 500 mg/dL on study Day 12. For that purpose the total serum IgG trough level will be measured on Day 12, i.e. 7 days after administration of the last loading dose of 100 mg/kg Vivaglobin on Day 5.<br>The primary efficacy endpoint consists of the proportion of patients achieving IgG levels =500 mg/dL on Day 12.

Secondary Outcome Measures

Name	Time	Method

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