Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is part of the BIVIGAM® post marketing requirement (PMR). It is being conducted in subjects aged 2-16 with primary immune deficiency disorders associated with defects in humoral immunity to generate additional data on these populations, and more specifically safety and pharmacokinetic (PK) assessments.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Drug | Other | All subjects will receive Bivigam based on their prior dosing to be adjusted as clinically necessary. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bivigam | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Temporally Associated Adverse Events | Incidence of adverse events (During or within 1 hour, 24 hours and 72 hours of completion of an infusion) | During each infusion (During or within 1 hour, 24 hours and 72 hours of completion of an infusion) |
| Number of Temporally Associated Adverse Events | Mean number of temporally associated per infusion | Up to 72 hours of completion of an infusion |
| Serious Adverse Events | Incidence of serious adverse events | Up to approximately 7 months |
| Related Serious Adverse Events | Incidence of related serious adverse events | Up to approximately 7 months |
| Treatment Emergent Adverse Events | Incidence of treatment emergent adverse events | Up to approximately 7 months |
| Related Treatment Emergent Averse Events | Incidence of adverse events that first appear, or that worsen relative to the pre-treatment state, which occur during and within 72 hours of treatment administration | Within 72 hours of infusion |
| Non-treatment Emergent Adverse Events | Incidence of adverse events which do not have a causal relationship with study treatment | Up to approximately 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total IgG Trough | Levels taken before any infusion | At each visit through study completion, up tp approximately 7 months |
| IgG subclasses | Levels of subclasses 1- 4 before infusion |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IMMUNOe Research Centers | Centennial | Colorado | 80112 | United States | ||
| Duke University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42218742 | Derived | Dumas T, Mehr S, Avila R, Doman A, Kestenberg K, Melamed I. Pharmacokinetic Model Based Sensitivity Analysis to Lower Recruitment Burden for Young Children Requiring Intravenous Immunoglobulin G Replacement. CPT Pharmacometrics Syst Pharmacol. 2026 Jun;15(6):e70275. doi: 10.1002/psp4.70275. |
Not provided
Not provided
Not yet determined
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 2, 2024 | |
| Reset | Feb 28, 2024 | |
| Release | Dec 11, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Temporally Associated Infusion Adverse Events | Incidence of adverse events which have a causal relationship with infusion treatment | Up to approximately 7 months |
| Adverse Reactions | Number and incidence of adverse reactions plus suspected adverse reactions combined | Up to approximately 7 months |
| Related Adverse Reactions | Incidence of adverse infusion related reactions | Up to approximately 7 months |
| Infusion Site Reactions | Incidence reactions occuring at the infusion site | Up to approximately 7 months |
| Vital Signs | Change in vital signs | Before and after each administration of study drug through study completion, up to approximately 7 months |
| Temporally Associated Adverse Events Following Infusions | Incidence of adverse events | Up to 72 hours after each infusion through study completion, up tp approximately 7 months |
| Prior to first and last infusion, up tp approximately 7 months |
| Total IgG Post | End of infusion level of Total IgG | At each infusion through study completion, up tp approximately 7 months |
| Cmax | Pharmacokinetic measure at 5th or 7th infusion | At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after final infusion, up tp approximately 7 months |
| Tmax | Pharmacokinetic measure at 5th or 7th infusion | At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after final infusion, up tp approximately 7 months |
| AUC(0-ʈ) | Pharmacokinetic measure at 5th or 7th infusion | At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after final infusion, up tp approximately 7 months |
| AUC(0-∞) | Pharmacokinetic measure at 5th or 7th infusion | At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after infusion |
| Terminal phase elimination half-life (ʈ½) | Pharmacokinetic measure at 5th or 7th infusion | At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after final infusion, up tp approximately 7 months |
| Antibodies | Levels of specific antibodies (antipneumococcal capsular polysaccharide, antihaemophilus influenza B | At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after final infusion, up tp approximately 7 months |
| Infections | Number of infections of any kind, serious and non-serious | Up to approximately 7 months |
| First Serious Bacterial Infection | Time to first Serious Bacterial Infections in days | Up to approximately 7 months |
| Serious Bacterial Infections | Incidence of Serious Bacterial Infections | Up to approximately 7 months |
| Other Infections | Incidence of infections other than Serious Bacterial Infections | Up to approximately 7 months |
| Resolution of Infections | Time to resolution of Infections in days | Up to approximately 7 months |
| Fever | Episodes of Fever | Up to approximately 7 months |
| Missed Days | Number of days missed of school or work due to infections and treatment | Up to approximately 7 months |
| Hospitalizations | Number of hospitalizations due to infections | Up to approximately 7 months |
| Terminal phase elimination rate (λZ) | Pharmacokinetic measure at 5th or 7th infusion | At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after final infusion, up tp approximately 7 months |
| Durham |
| Florida |
| 27710 |
| United States |
| Allergy Associates of the Palm Beaches | North Palm Beach | Florida | 33408 | United States |
| USF Health, Pediatric Allergy, Immunology & Rheumatology | St. Petersburg | Florida | 33701 | United States |
| Ohio Clinical Research Associates | Mayfield Heights | Ohio | 44124 | United States |
| Oklahoma Institute of Allergy and Asthma Clinical Research | Oklahoma City | Oklahoma | 73131 | United States |
| Discovery Clinical Trials | Dallas | Texas | 75225 | United States |
| Lysosomal Rare Disorders Research & Treatment Center | Fairfax | Virginia | 22030 | United States |
| Reset | Dec 31, 2025 |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 2, 2024 | Feb 28, 2024 | |||
| Dec 11, 2025 | Dec 31, 2025 |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| ID | Term |
|---|---|
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided