Clincosm LogoSign in Get a demo

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

Sponsor
Green Cross Corporation (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT03492710
Collaborator
(none)
0
Enrollment
1
Arm

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Immunoglobulin
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Open-Label, Single-Arm, Historically Controlled, Prospective, MulticenterOpen-Label, Single-Arm, Historically Controlled, Prospective, Multicenter
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase III Study of Immune Globulin Intravenous (Human) IGIV-SN in Pediatric Subjects With Primary Humoral Immunodeficiency
Actual Study Start Date :
Apr 30, 2019
Actual Primary Completion Date :
Apr 30, 2019
Actual Study Completion Date :
Apr 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: IGIV-SN

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    1. Efficacy: Incidence of Infections other than acute serious bacterial infections [13 months (12 months of treatment + 1 month of Follow-Up)]

    2. 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)

    Other Outcome Measures

    1. PK Endpoint (1) [13 months (12 months of treatment + 1 month of Follow-Up)]

      Plasma Concentration-Time Curve (PK Parameters of Total IgG)

    2. PK Endpoint (2) [13 months (12 months of treatment + 1 month of Follow-Up)]

      Area Under the Curve (PK Parameters of Total IgG)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    24 Months to 203 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Green Cross Corporation

    Investigators

    • Principal Investigator: Chaim Roifman, The Hospital for Sick Children

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Green Cross Corporation
    ClinicalTrials.gov Identifier:
    NCT03492710
    Other Study ID Numbers:
    • GC5101F
    First Posted:
    Apr 10, 2018
    Last Update Posted:
    Jul 7, 2020
    Last Verified:
    Jul 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Primary Immunodeficiency Diseases
    Immunologic Deficiency Syndromes
    Immunoglobulins
    Immunoglobulins, Intravenous
    Antibodies

    Study Results

    No Results Posted as of Jul 7, 2020