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

Primary Immune Deficiency Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03492710
• Other study ID #: GC5101F
• Status: Withdrawn
• Phase: Phase 3
• Start date: April 30, 2019
• Est. completion date: April 30, 2019

Study information

• Verified date: July 2020
• Source: Green Cross Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Months to 203 Months

Eligibility

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

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Primary Immune Deficiency Disorder

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Green Cross Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PK Endpoint (1)	Plasma Concentration-Time Curve (PK Parameters of Total IgG)	13 months (12 months of treatment + 1 month of Follow-Up)
Other	PK Endpoint (2)	Area Under the Curve (PK Parameters of Total IgG)	13 months (12 months of treatment + 1 month of Follow-Up)
Primary	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)
Primary	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	Efficacy: Incidence of Infections other than acute serious bacterial infections		13 months (12 months of treatment + 1 month of Follow-Up)
Secondary	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)