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

Primary Immune Deficiency Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04565015
• Other study ID #: GC5107D
• Status: Recruiting
• Phase: Phase 3
• Start date: December 21, 2020
• Est. completion date: November 2023

Study information

• Verified date: May 2023
• Source: GC Biopharma Corp
• Contact: Hyejoo Kim
• Phone: +82-31-260-9192
• Email: hyejoo.kim[@]gccorp.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 < 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: November 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Primary Immune Deficiency
• Primary Immunodeficiency Diseases

Intervention

Biological:
• GC5107
Intravenously infused at a dose of 300 - 900 mg per kg (of body weight) every 21 or 28 days for 12 months

Locations

Country	Name	City	State
United States	Allergy Partners of North Texas Research	Dallas	Texas
United States	Lysosomal and Rare Disorders Research and Treatment Center, Inc.	Fairfax	Virginia
United States	University of Wisconsin	Milwaukee	Wisconsin
United States	Oklahoma Institute of Allergy & Asthma Clinical Research, LLC	Oklahoma City	Oklahoma
United States	Children's Hospital of Richmond at VCU	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Green Cross Corporation	Atlantic Research Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)		13 months (12 months of treatment + 1 month of follow-up)
Other	The incidence of infections other than acute serious bacterial infections		13 months (12 months of treatment + 1 month of follow-up)
Other	The number of days missed from work, school, kindergarten, day care or days unable to perform normal daily activities due to infections		13 months (12 months of treatment + 1 month of follow-up)
Other	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		13 months (12 months of treatment + 1 month of follow-up)
Other	The number of days of unscheduled physician visits due to infection		13 months (12 months of treatment + 1 month of follow-up)
Other	The number of days of hospitalizations due to infection		13 months (12 months of treatment + 1 month of follow-up)
Other	The number of days of intravenous (IV) therapeutic antibiotics		13 months (12 months of treatment + 1 month of follow-up)
Other	The number of days of oral (PO) therapeutic antibiotics		13 months (12 months of treatment + 1 month of follow-up)
Other	Time to resolution of infections		13 months (12 months of treatment + 1 month of follow-up)
Other	The incidence of infections by trough IgG levels		13 months (12 months of treatment + 1 month of follow-up)
Other	Episodes of fever (annual rate of fever episodes per subject)		13 months (12 months of treatment + 1 month of follow-up)
Primary	The Pharmacokinetic (PK) Plasma concentration-time curve of total IgG		before and after 5th infusion (12 or 16 weeks)
Primary	The Pharmacokinetic (PK) Half-life of total IgG		before and after 5th infusion (12 or 16 weeks)
Primary	The Pharmacokinetic (PK) Area under the curve of total IgG		before and after 5th infusion (12 or 16 weeks)
Primary	The Pharmacokinetic (PK) Volume of distribution of total IgG		before and after 5th infusion (12 or 16 weeks)
Primary	The Pharmacokinetic (PK) Maximum concentration of total IgG		before and after 5th infusion (12 or 16 weeks)
Primary	The Pharmacokinetic (PK) Minimum concentration of total IgG		before and after 5th infusion (12 or 16 weeks)
Primary	The Pharmacokinetic (PK) Time of maximum concentration of total IgG		before and after 5th infusion (12 or 16 weeks)
Primary	The Pharmacokinetic (PK) Clearance of total IgG		before and after 5th infusion (12 or 16 weeks)
Primary	Trough serum total IgG levels before each infusion of GC5107 in all subjects and the interval between infusions		12 months
Primary	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	AEs that occur during or within 1 hour, 24 hours, and 72 hours following each infusion during 12 months of the study period	12 months
Secondary	The Pharmacokinetic (PK) Maximum concentration of IgG subclasses		before and after 5th infusion (12 or 16 weeks)
Secondary	The Pharmacokinetic (PK) Minimum concentration of IgG subclasses		before and after 5th infusion (12 or 16 weeks)
Secondary	The Pharmacokinetic (PK) Half-life of IgG subclasses		before and after 5th infusion (12 or 16 weeks)
Secondary	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)		12 months
Secondary	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)		12 months
Secondary	The overall incidence of all AEs that occur during or within 1 hour, 24 hours, and 72 hours following an infusion of investigational product	AEs that occur during or within 1 hour, 24 hours, and 72 hours following each infusion during 12 months of the study period	12 months
Secondary	The frequency of all AEs that occur during the study regardless of the investigator's assessment of their relationship to investigational product		13 months (12 months of treatment + 1 month of follow-up)
Secondary	The frequency of suspected adverse reactions as defined by all AEs either classified as at least possibly related to GC5107		13 months (12 months of treatment + 1 month of follow-up)
Secondary	The number and proportion of GC5107 infusions for which the infusion rate was decreased due to AEs		12 months
Secondary	The proportion of AEs considered by the investigator to be investigational product related		13 months (12 months of treatment + 1 month of follow-up)
Secondary	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		13 months (12 months of treatment + 1 month of follow-up)