Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency

  • STATUS
    Recruiting
  • End date
    Nov 22, 2023
  • participants needed
    16
  • sponsor
    Green Cross Corporation
Updated on 22 June 2021

Summary

The purpose of this study is to evaluate the pharmacokinetics and safety of Immune Globulin Intravenous (Human) GC5107 in pediatric subjects with Primary Humoral Immunodeficiency (PHID).

Description

This is a prospective, open-label, single-arm, historically controlled, multi-center Phase III study to assess the pharmacokinetics and safety of Immune Globulin Intravenous (Human) GC5107 in pediatric subjects aged 2 years and < 12 years with PHID.

Subjects will receive intravenous infusions of the investigational product at the same dose and interval as used for their previous Immunoglobulin intravenous (IGIV) maintenance therapy. GC5107 will be infused every 21 or 28 days for a period of 12 months.

Details
Condition Primary Immunodeficiency, Primary Immune Deficiency, Primary Immunodeficiency Disorders, Primary Immune Deficiencies
Treatment GC5107
Clinical Study IdentifierNCT04565015
SponsorGreen Cross Corporation
Last Modified on22 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject must be 2 to < 12 years of age, at the time of signing the informed consent
Pediatric subject has a confirmed and documented clinical diagnosis of Primary Humoral Immunodeficiency, including hypogammaglobulinemia or agammaglobulinemia
Subject who has received 300 - 900 mg/kg of IGIV therapy at 21 or 28 day intervals for at least 3 months prior to this study
Subject who has at least 2 documented plasma IgG trough level of 500 mg/dL at two infusion cycles (21 or 28 days) within 12 months prior to enrollment
Subject who is willing to comply with all requirements of the protocol

Exclusion Criteria

Subject who has a history of clinically significant reactions or hypersensitivity to IGIV or other injectable forms of IgG
Subject who has IgA deficiency and is known to have antibodies to IgA
Subject who has secondary immunodeficiency
Subject who has participated in another clinical study (other than an IGIV study) within 3 weeks prior to screening
Subject who has been diagnosed with dysgammaglobulinemia or isolated IgG subclass deficiency or isolated IgA deficiency, or who has clinically significant impairment of cellular or innate immunity at the discretion of the Investigator
Subject who has received blood products other than human albumin or human immune globulin within 6 months prior to enrollment
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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