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

NCT03492710 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: GC5101F
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Primary Immune Deficiency Disorder

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (2)

• 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)

Other Outcomes (2)

• PK Endpoint (1)

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

• PK Endpoint (2)

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

Study Arms (1)

IGIV-SN

EXPERIMENTAL

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

Biological: Immunoglobulin

Interventions

Immunoglobulin BIOLOGICAL

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

Also known as: IGIV-SN

IGIV-SN

Eligibility Criteria

• Age: 24 Months - 203 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Green Cross Corporation: lead

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Interventions

Immunoglobulins

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Chaim Roifman

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: April 10, 2018
• Study Start: April 30, 2019
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: July 7, 2020

Record last verified: 2020-07