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NCT Number: NCT04565015

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Primary Immune Deficiency Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Clinical Center Sarajevo, Sarajevo, Bosnia and Herzegovina

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About this study

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 < 17 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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

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

Treatment and study plan

GC5107

Biological

Intravenously infused at a dose of 300 - 900 mg per kg (of body weight) every 21 or 28 days for 12 months

Other names: GCC 10% IGIV, Immune Globulin Intravenous (Human), 10% Liquid

Primary outcomes

  1. The Pharmacokinetic (PK) Plasma concentration-time curve of total IgG

    Time frame: before and after 5th infusion (12 or 16 weeks)

  2. The Pharmacokinetic (PK) Half-life of total IgG

    Time frame: before and after 5th infusion (12 or 16 weeks)

  3. The Pharmacokinetic (PK) Area under the curve of total IgG

    Time frame: before and after 5th infusion (12 or 16 weeks)

  4. The Pharmacokinetic (PK) Volume of distribution of total IgG

    Time frame: before and after 5th infusion (12 or 16 weeks)

  5. The Pharmacokinetic (PK) Maximum concentration of total IgG

    Time frame: before and after 5th infusion (12 or 16 weeks)

  6. The Pharmacokinetic (PK) Minimum concentration of total IgG

    Time frame: before and after 5th infusion (12 or 16 weeks)

  7. The Pharmacokinetic (PK) Time of maximum concentration of total IgG

    Time frame: before and after 5th infusion (12 or 16 weeks)

  8. The Pharmacokinetic (PK) Clearance of total IgG

    Time frame: before and after 5th infusion (12 or 16 weeks)

  9. Trough serum total IgG levels before each infusion of GC5107 in all subjects and the interval between infusions

    Time frame: 12 months

  10. The proportion of infusions with temporally associated adverse events (AEs) that occur during or within 1 hour, 24 hours, and 72 hours following an infusion of investigational product

    Time frame: 12 months

    AEs that occur during or within 1 hour, 24 hours, and 72 hours following each infusion during 12 months of the study period

Secondary outcomes

  1. The Pharmacokinetic (PK) Maximum concentration of IgG subclasses

    Time frame: before and after 5th infusion (12 or 16 weeks)

  2. The Pharmacokinetic (PK) Minimum concentration of IgG subclasses

    Time frame: before and after 5th infusion (12 or 16 weeks)

  3. The Pharmacokinetic (PK) Half-life of IgG subclasses

    Time frame: before and after 5th infusion (12 or 16 weeks)

  4. Trough serum level of IgG subclasses and specific IgG antibodies before Infusion 1 and 13 (for subjects on 28-day infusion schedule) or Infusion 1 and 17 (for subjects on 21-day infusion schedule)

    Time frame: 12 months

  5. Number and proportion of subjects who failed to meet the target IgG trough level (500 mg/dL) at any time point equal to or subsequent to 5th infusion (estimated 5 half-lives)

    Time frame: 12 months

  6. The overall incidence of all AEs that occur during or within 1 hour, 24 hours, and 72 hours following an infusion of investigational product

    Time frame: 12 months

    AEs that occur during or within 1 hour, 24 hours, and 72 hours following each infusion during 12 months of the study period

  7. The frequency of all AEs that occur during the study regardless of the investigator's assessment of their relationship to investigational product

    Time frame: 13 months (12 months of treatment + 1 month of follow-up)

  8. The frequency of suspected adverse reactions as defined by all AEs either classified as at least possibly related to GC5107

    Time frame: 13 months (12 months of treatment + 1 month of follow-up)

  9. The number and proportion of GC5107 infusions for which the infusion rate was decreased due to AEs

    Time frame: 12 months

  10. The proportion of AEs considered by the investigator to be investigational product related

    Time frame: 13 months (12 months of treatment + 1 month of follow-up)

  11. Viral safety (freedom from transmission of blood-borne viral diseases): the human immunodeficiency virus (HIV) type 1 & 2, hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), and parvovirus B19

    Time frame: 13 months (12 months of treatment + 1 month of follow-up)

Other outcomes

  1. The incidence of acute serious bacterial infections (aSBIs) defined at United States Food and Drug Administration (FDA) guidance criteria (bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis)

    Time frame: 13 months (12 months of treatment + 1 month of follow-up)

  2. The incidence of infections other than acute serious bacterial infections

    Time frame: 13 months (12 months of treatment + 1 month of follow-up)

  3. The number of days missed from work, school, kindergarten, day care or days unable to perform normal daily activities due to infections

    Time frame: 13 months (12 months of treatment + 1 month of follow-up)

  4. The number of days that the care provider of the pediatric subject had to miss work in order to care for the child due to infections

    Time frame: 13 months (12 months of treatment + 1 month of follow-up)

  5. The number of days of unscheduled physician visits due to infection

    Time frame: 13 months (12 months of treatment + 1 month of follow-up)

  6. The number of days of hospitalizations due to infection

    Time frame: 13 months (12 months of treatment + 1 month of follow-up)

  7. The number of days of intravenous (IV) therapeutic antibiotics

    Time frame: 13 months (12 months of treatment + 1 month of follow-up)

  8. The number of days of oral (PO) therapeutic antibiotics

    Time frame: 13 months (12 months of treatment + 1 month of follow-up)

  9. Time to resolution of infections

    Time frame: 13 months (12 months of treatment + 1 month of follow-up)

  10. The incidence of infections by trough IgG levels

    Time frame: 13 months (12 months of treatment + 1 month of follow-up)

  11. Episodes of fever (annual rate of fever episodes per subject)

    Time frame: 13 months (12 months of treatment + 1 month of follow-up)

Sponsors and collaborators

Lead sponsor

GC Biopharma Corp

Industry

Collaborators

  • Atlantic Research Group

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2020
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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