ACTIVE_NOT_RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2020-12-21

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04565015

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.

Ages Eligible for Study:2 Years to 16 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Locations (Sites)

Children's Hospital Colorado

Aurora, Colorado, 80045

United States

Immunoe Health & Research Centers

Centennial, Colorado, 80112

United States

Allergy Partners of North Texas Research

Dallas, Texas, 75230

United States

Lysosomal and Rare Disorders Research and Treatment Center, Inc.

Fairfax, Virginia, 22030

United States

Children's Hospital of Richmond at VCU

Richmond, Virginia, 23219

United States

Collaborators and Investigators

Sponsor: GC Biopharma Corp

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-21

Study Completion Date2026-11

Study Record Updates

Study Start Date2020-12-21

Study Completion Date2026-11

Terms related to this study

Additional Relevant MeSH Terms

Primary Immune Deficiency