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

Green Cross Corporation

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Primary Immune Deficiency Disorder

Interventions

ImmunoglobulinBIOLOGICAL

Administer volume of IGIV-SN to maintain a trough level of of 5g/L or more

Eligibility

Sex: ALLMin age: 24 MonthsMax age: 203 Months

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 13 months (12 months of treatment + 1 month of Follow-Up)

Secondary Outcomes

Efficacy: Incidence of Infections other than acute serious bacterial infections

Time frame: 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)

Time frame: 13 months (12 months of treatment + 1 month of Follow-Up)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.