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

Phase 3

Withdrawn

• Conditions: Primary Immune Deficiency Disorder
• Interventions: Biological: Immunoglobulin

• Registration Number: NCT03492710
• Lead Sponsor: Green Cross Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-19
• Study First Submitted QC: 2018-04-08
• Study First Posted: 2018-04-10
• Study Start: 2019-04-30
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-01
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IGIV-SN	Immunoglobulin	Immunoglobulin, Supplied in 5g (100mL) and/or 10g (200mL)

Primary Outcome Measures

Name	Time	Method
Efficacy: Incidence of Acute SBIs (Serious Bacterial Infections)	13 months (12 months of treatment + 1 month of Follow-Up)	The incidence of acute serious bacterial infections, i.e. bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, osteomyelitis/ septic arthritis, visceral abscess
Safety: Overall Incidence of AEs that occur during 72 hours of following an infusion of test drug	13 months (12 months of treatment + 1 month of Follow-Up)	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

Secondary Outcome Measures

Name	Time	Method
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	13 months (12 months of treatment + 1 month of Follow-Up)	(regardless of the casual relationship)