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

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03492710

Enrollment

Registered

2018-04-10

Start date

2019-04-30

Completion date

2019-04-30

Last updated

2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Immune Deficiency Disorder

Brief summary

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

Interventions

BIOLOGICALImmunoglobulin

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter

Eligibility

Sex/Gender

ALL

Age

24 Months to 203 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)
Efficacy: Incidence of Infections other than acute serious bacterial infections	13 months (12 months of treatment + 1 month of Follow-Up)	—

Other

Measure	Time frame	Description
PK Endpoint (1)	13 months (12 months of treatment + 1 month of Follow-Up)	Plasma Concentration-Time Curve (PK Parameters of Total IgG)
PK Endpoint (2)	13 months (12 months of treatment + 1 month of Follow-Up)	Area Under the Curve (PK Parameters of Total IgG)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026