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A change in sponsor's developmental strategy
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To assess the safety, efficacy, and pharmacokinetics of IGIV-SN in pediatric subjects with primary immunodeficiency humoral diseases (PHID)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IGIV-SN | Experimental | Immunoglobulin, Supplied in 5g (100mL) and/or 10g (200mL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunoglobulin | Biological | Administer volume of IGIV-SN to maintain a trough level of of 5g/L or more |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Incidence of Acute SBIs (Serious Bacterial Infections) | The incidence of acute serious bacterial infections, i.e. bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, osteomyelitis/ septic arthritis, visceral abscess | 13 months (12 months of treatment + 1 month of Follow-Up) |
| Safety: Overall Incidence of AEs that occur during 72 hours of following an infusion of test drug | The overall incidence of adverse events (AEs) that occur during or within 1 hours, 24 hours, and 72 hours following an infusion of test product, regardless of whether or not the AE is determined to be product related | 13 months (12 months of treatment + 1 month of Follow-Up) |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Incidence of Infections other than acute serious bacterial infections | 13 months (12 months of treatment + 1 month of Follow-Up) | |
| Safety: The frequency of all AEs that occuring during the study | (regardless of the casual relationship) |
| Measure | Description | Time Frame |
|---|---|---|
| PK Endpoint (1) | Plasma Concentration-Time Curve (PK Parameters of Total IgG) | 13 months (12 months of treatment + 1 month of Follow-Up) |
| PK Endpoint (2) | Area Under the Curve (PK Parameters of Total IgG) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chaim Roifman | The Hospital for Sick Children | Principal Investigator |
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| 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 |
|---|---|
| D007136 | Immunoglobulins |
| ID | Term |
|---|---|
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter
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| 13 months (12 months of treatment + 1 month of Follow-Up) |
| 13 months (12 months of treatment + 1 month of Follow-Up) |
| D012712 |
| Serum Globulins |
| D005916 | Globulins |