Study of Immune Globulin Intravenous (Human) GC5101F in Subjects With Primary Humoral Immunodeficiency

Study Overview
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Brief Summary
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To assess the safety, efficacy, and pharmacokinetics of IGIV-SN in pediatric subjects with primary immunodeficiency humoral diseases (PHID)

Official Title
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Phase III Study of Immune Globulin Intravenous (Human) IGIV-SN in Pediatric Subjects With Primary Humoral Immunodeficiency

Conditions
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Primary Immune Deficiency Disorder

Intervention / Treatment
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* Biological: Immunoglobulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric subjects with a confirmed clinical diagnosis of a Primary Humoral Immunodeficiency Disease as defined by IUIS (International Union of Immunological Societies) and require treatment with IGIV. Documented agammaglobulinemia or hypogammaglobulinemia Subject is willing to comply with all requirements of protocol Authorization to access personal health information Exclusion Criteria: Subject has secondary immunodeficiency Subject has a history of repeated reactions or hypersensitivity to IGIV or other injectable forms of IgG Subject has significant protein loss from enteropathy, nephrotic syndrome or lymphangiectasia

Ages Eligible for Study
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Minimum Age: 24 Months
Maximum Age: 203 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IGIV-SN<br>Immunoglobulin, Supplied in 5g (100mL) and/or 10g (200mL) | Biological: Immunoglobulin<br>* Administer volume of IGIV-SN to maintain a trough level of of 5g/L or more<br>* Other names: IGIV-SN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Incidence of Acute SBIs (Serious Bacterial Infections) | The incidence of acute serious bacterial infections, i.e. bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, osteomyelitis/ septic arthritis, visceral abscess | 13 months (12 months of treatment + 1 month of Follow-Up) | 
| Safety: Overall Incidence of AEs that occur during 72 hours of following an infusion of test drug | The overall incidence of adverse events (AEs) that occur during or within 1 hours, 24 hours, and 72 hours following an infusion of test product, regardless of whether or not the AE is determined to be product related | 13 months (12 months of treatment + 1 month of Follow-Up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Incidence of Infections other than acute serious bacterial infections |  | 13 months (12 months of treatment + 1 month of Follow-Up) | 
| Safety: The frequency of all AEs that occuring during the study | (regardless of the casual relationship) | 13 months (12 months of treatment + 1 month of Follow-Up) |