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| Name | Class |
|---|---|
| Atlantic Research Group | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GC5107 | Experimental | Immune Globulin Intravenous (Human), 10% Liquid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GC5107 | Biological | Intravenously infused at a dose of 300 - 900 mg per kg (of body weight) every 21 or 28 days for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Pharmacokinetic (PK) Plasma concentration-time curve of total IgG | before and after 5th infusion (12 or 16 weeks) | |
| The Pharmacokinetic (PK) Half-life of total IgG | before and after 5th infusion (12 or 16 weeks) | |
| The Pharmacokinetic (PK) Area under the curve of total IgG | before and after 5th infusion (12 or 16 weeks) | |
| The Pharmacokinetic (PK) Volume of distribution of total IgG | before and after 5th infusion (12 or 16 weeks) | |
| The Pharmacokinetic (PK) Maximum concentration of total IgG | before and after 5th infusion (12 or 16 weeks) | |
| The Pharmacokinetic (PK) Minimum concentration of total IgG | before and after 5th infusion (12 or 16 weeks) | |
| The Pharmacokinetic (PK) Time of maximum concentration of total IgG | before and after 5th infusion (12 or 16 weeks) | |
| The Pharmacokinetic (PK) Clearance of total IgG | before and after 5th infusion (12 or 16 weeks) | |
| Trough serum total IgG levels before each infusion of GC5107 in all subjects and the interval between infusions | 12 months | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The Pharmacokinetic (PK) Maximum concentration of IgG subclasses | before and after 5th infusion (12 or 16 weeks) | |
| The Pharmacokinetic (PK) Minimum concentration of IgG subclasses | before and after 5th infusion (12 or 16 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | |
| The incidence of infections other than acute serious bacterial infections |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States | ||
| Immunoe Health & Research Centers |
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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 |
| The Pharmacokinetic (PK) Half-life of IgG subclasses | before and after 5th infusion (12 or 16 weeks) |
| 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 |
| 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 |
| 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 |
| 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) |
| 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) |
| The number and proportion of GC5107 infusions for which the infusion rate was decreased due to AEs | 12 months |
| The proportion of AEs considered by the investigator to be investigational product related | 13 months (12 months of treatment + 1 month of follow-up) |
| 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) |
| 13 months (12 months of treatment + 1 month of follow-up) |
| 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) |
| 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) |
| The number of days of unscheduled physician visits due to infection | 13 months (12 months of treatment + 1 month of follow-up) |
| The number of days of hospitalizations due to infection | 13 months (12 months of treatment + 1 month of follow-up) |
| The number of days of intravenous (IV) therapeutic antibiotics | 13 months (12 months of treatment + 1 month of follow-up) |
| The number of days of oral (PO) therapeutic antibiotics | 13 months (12 months of treatment + 1 month of follow-up) |
| Time to resolution of infections | 13 months (12 months of treatment + 1 month of follow-up) |
| The incidence of infections by trough IgG levels | 13 months (12 months of treatment + 1 month of follow-up) |
| Episodes of fever (annual rate of fever episodes per subject) | 13 months (12 months of treatment + 1 month of follow-up) |
| 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 |
| University Clinical Center Sarajevo | Sarajevo | Sarajevo | 71000 | Bosnia and Herzegovina |
| University clinical center Tuzla | Tuzla | Tuzla | 75000 | Bosnia and Herzegovina |
| Institute for Child and Youth Health Care of Vojvodina | Novi Sad | Novi Sad | 21000 | Serbia |
| ID | Term |
|---|---|
| D000081207 | Primary Immunodeficiency Diseases |
| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D005719 | gamma-Globulins |
| D005440 | Fluid Therapy |
| ID | Term |
|---|---|
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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