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

Primary Purpose

Primary Immune Deficiency Disorder

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Immunoglobulin
Sponsored by
Green Cross Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Immune Deficiency Disorder

Eligibility Criteria

24 Months - 203 Months (Child)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    IGIV-SN

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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
    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

    Secondary Outcome Measures

    Efficacy: Incidence of Infections other than acute serious bacterial infections
    Safety: The frequency of all AEs that occuring during the study
    (regardless of the casual relationship)

    Full Information

    First Posted
    February 19, 2018
    Last Updated
    July 1, 2020
    Sponsor
    Green Cross Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03492710
    Brief Title
    Study of Immune Globulin Intravenous (Human) GC5101F in Subjects With Primary Humoral Immunodeficiency
    Official Title
    Phase III Study of Immune Globulin Intravenous (Human) IGIV-SN in Pediatric Subjects With Primary Humoral Immunodeficiency
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    A change in sponsor's developmental strategy
    Study Start Date
    April 30, 2019 (Actual)
    Primary Completion Date
    April 30, 2019 (Actual)
    Study Completion Date
    April 30, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Green Cross Corporation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Immune Deficiency Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Model Description
    Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    IGIV-SN
    Arm Type
    Experimental
    Arm Description
    Immunoglobulin, Supplied in 5g (100mL) and/or 10g (200mL)
    Intervention Type
    Biological
    Intervention Name(s)
    Immunoglobulin
    Other Intervention Name(s)
    IGIV-SN
    Intervention Description
    Administer volume of IGIV-SN to maintain a trough level of of 5g/L or more
    Primary Outcome Measure Information:
    Title
    Efficacy: Incidence of Acute SBIs (Serious Bacterial Infections)
    Description
    The incidence of acute serious bacterial infections, i.e. bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, osteomyelitis/ septic arthritis, visceral abscess
    Time Frame
    13 months (12 months of treatment + 1 month of Follow-Up)
    Title
    Safety: Overall Incidence of AEs that occur during 72 hours of following an infusion of test drug
    Description
    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
    Time Frame
    13 months (12 months of treatment + 1 month of Follow-Up)
    Secondary Outcome Measure Information:
    Title
    Efficacy: Incidence of Infections other than acute serious bacterial infections
    Time Frame
    13 months (12 months of treatment + 1 month of Follow-Up)
    Title
    Safety: The frequency of all AEs that occuring during the study
    Description
    (regardless of the casual relationship)
    Time Frame
    13 months (12 months of treatment + 1 month of Follow-Up)
    Other Pre-specified Outcome Measures:
    Title
    PK Endpoint (1)
    Description
    Plasma Concentration-Time Curve (PK Parameters of Total IgG)
    Time Frame
    13 months (12 months of treatment + 1 month of Follow-Up)
    Title
    PK Endpoint (2)
    Description
    Area Under the Curve (PK Parameters of Total IgG)
    Time Frame
    13 months (12 months of treatment + 1 month of Follow-Up)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    24 Months
    Maximum Age & Unit of Time
    203 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chaim Roifman
    Organizational Affiliation
    The Hospital for Sick Children
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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