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

Green Cross Corporation

Status and phase: Withdrawn; Phase 3

Conditions: Primary Immune Deficiency Disorder

Treatments: Biological: Immunoglobulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03492710

GC5101F

Details and patient eligibility

About

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

Sex: All

Ages: 24 to 203 months old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

IGIV-SN

Experimental group

Description:

Immunoglobulin, Supplied in 5g (100mL) and/or 10g (200mL)

Treatment:

Biological: Immunoglobulin