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

Description

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).

Conditions

Primary Immune Deficiency

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Study Overview

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Study Details

Study overview

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).

An Open-Label, Single-Arm, Historically Controlled, Prospective, Multi-Center Phase III Study to Evaluate the Pharmacokinetics and Safety of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency

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

Condition
Primary Immune Deficiency
Intervention / Treatment

-

Contacts and Locations

Oklahoma City

Oklahoma Institute of Allergy & Asthma Clinical Research, LLC, Oklahoma City, Oklahoma, United States, 73131

Dallas

Allergy Partners of North Texas Research, Dallas, Texas, United States, 75230

Fairfax

Lysosomal and Rare Disorders Research and Treatment Center, Inc., Fairfax, Virginia, United States, 22030

Richmond

Children's Hospital of Richmond at VCU, Richmond, Virginia, United States, 23219

Milwaukee

University of Wisconsin, Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Subject must be ≥ 2 to \< 17 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
  • * 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

Ages Eligible for Study

2 Years to 16 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Green Cross Corporation,

Study Record Dates

2023-11