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

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ClinicalTrials.gov Identifier: NCT03492710
Recruitment Status : Not yet recruiting
First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation

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
Primary Immune Deficiency Disorder Biological: Immunoglobulin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open-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
Estimated Study Start Date : June 30, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021


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 Name: IGIV-SN




Primary Outcome Measures :
  1. Efficacy: Incidence of Acute SBIs (Serious Bacterial Infections) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 13 months (12 months of treatment + 1 month of Follow-Up) ]
  2. Safety: The frequency of all AEs that occuring during the study [ Time Frame: 13 months (12 months of treatment + 1 month of Follow-Up) ]
    (regardless of the casual relationship)


Other Outcome Measures:
  1. PK Endpoint (1) [ Time Frame: 13 months (12 months of treatment + 1 month of Follow-Up) ]
    Plasma Concentration-Time Curve (PK Parameters of Total IgG)

  2. PK Endpoint (2) [ Time Frame: 13 months (12 months of treatment + 1 month of Follow-Up) ]
    Area Under the Curve (PK Parameters of Total IgG)



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492710


Contacts
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Contact: JI Lee +82-32-260-1968 jylee817@greencross.com

Sponsors and Collaborators
Green Cross Corporation
Investigators
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Principal Investigator: Chaim Roifman The Hospital for Sick Children

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Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT03492710     History of Changes
Other Study ID Numbers: GC5101F
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulins
Antibodies
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs