Immunologic Deficiency Syndrome
Conditions
Keywords
IGIV, Primary Immune Deficiency, Immunoglobulin G
Brief summary
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with primary immunodeficiency diseases.
Detailed description
This is an open-label, single-arm, historically controlled, prospective, multicenter phase III study to evaluate the safety, efficacy and pharmacokinetics of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with primary immunodeficiency diseases. Subject will be infused every 21 to 28 days according to their previous IVIG treatment schedule. Subjects treated every 28 days will receive 13 study IVIG infusions. Subject treated every 21 days will receive 17 study IVIG infusions. Duration of treatment:The total duration of treatment is 12 months.
Interventions
DRUGImmune Globulin Intravenous (Human) 5% Liquid, IVIG-SN™
IVIG-SN™ 10g/200mL, dose is 300-900 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with IVIG-SN™ will be 12 months with a 3 month follow-up.
Sponsors
Atlantic Research Group
Green Cross Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with a confirmed clinical diagnosis of a Primary Immunodeficiency Disease as defined by IUIS (International Union of Immunological Societies) and require treatment with IVIG. Documented agammaglobulinemia or hypogammaglobulinemia (preferably with documented antibody deficiency). * Male or female, ages 2 to 70 years. * The subject has received 300-900 mg/kg of a licensed IGIV therapy at 21 or 28 day intervals for at least 3 months prior to this study. * At least 2 documented IgG trough levels of ≥ 5 g/L are obtained at two infusion cycles (21 or 28 days) within 12 months prior to study enrollment. * Subject is willing to comply with all requirements of the protocol. * Females of child-bearing potential with a negative urine pregnancy test and who agree to employ adequate birth control measures during the study. * Subject, parent or guardian has signed the informed consent form and a child assent form if appropriate. Pediatric subjects are defined as 2-17 years of age at study entry and will require assent forms as appropriate per study documentation and regulations of the local jurisdiction. * Authorization to access personal health information. * Subjects currently participating in a clinical trial with another experimental IVIG may be enrolled if they have received stable IVIG therapy for at least 3 infusion cycles prior to receiving IVIG-SN™ and all inclusion and
Exclusion criteria
are satisfied. Other IVIGs will be prohibited between the first infusion of IVIG-SN™ and Follow Up Visit 1. * Subjects currently participating in a trial of SCIG can be enrolled if they are switched to IVIG for three infusion cycles (21 or 28 days) prior to enrollment in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of acute serious bacterial infections | one year |
| Overall incidence of adverse events that occur during or within 1 hour, 24 hours and 72 hours following an infusion of test product | Within 72 hours after treatment with IVIG-SN |
| The Pharmacokinetic (PK) Area under the curve (AUC0-t, AUC0-inf) of Immunoglobulin G (IgG). | After 5th infusion |
| The Pharmacokinetic (PK) Maximum concentration (Cmax) of Immunoglobulin G (IgG). | After 5th infusion |
Secondary
| Measure | Time frame |
|---|---|
| Annual rate of fever episodes per patient | One year |
| All adverse events regardless of causality assessment by investigator | One year |
| The proportion and number of IGIV infusions for which the infusion rate was decreased due to adverse events | One year |
| The number of days missed work/school/kindergarten/day care or unable to perform normal daily activities due to infection. | one year |
| To monitor viral safety (freedom from transmission of blood borne virus diseases) | One year |
| Descriptive analyses of PK parameters for specific antibodies (anti-Hemophilus influenza type b, anti-Streptococcus pneumonia serotypes, anti-Tetanus toxoid, anti-cytomegalovirus (CMV), anti-measles) will be performed. | One year |
| The proportion of adverse events considered by the investigator to be product related | One year |
| Days of unscheduled physician visits and hospitalizations due to infection | One year |
| Number of days on therapeutic antibiotics | One year |
| The incidence of infections other than acute serious bacterial infections | One year |
Countries
Canada, United States
Outcome results
None listed