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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
16
IMMUNOe Research Centers
Centennial, Colorado, United States
Duke University Medical Center
Durham, Florida, United States
Allergy Associates of the Palm Beaches
North Palm Beach, Florida, United States
USF Health, Pediatric Allergy, Immunology & Rheumatology
Temporally Associated Adverse Events
Incidence of adverse events (During or within 1 hour, 24 hours and 72 hours of completion of an infusion)
Time frame: 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
Time frame: Up to 72 hours of completion of an infusion
Serious Adverse Events
Incidence of serious adverse events
Time frame: Up to approximately 7 months
Related Serious Adverse Events
Incidence of related serious adverse events
Time frame: Up to approximately 7 months
Treatment Emergent Adverse Events
Incidence of treatment emergent adverse events
Time frame: 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
Time frame: Within 72 hours of infusion
Non-treatment Emergent Adverse Events
Incidence of adverse events which do not have a causal relationship with study treatment
Time frame: Up to approximately 7 months
Temporally Associated Infusion Adverse Events
Incidence of adverse events which have a causal relationship with infusion treatment
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St. Petersburg, Florida, United States
Ohio Clinical Research Associates
Mayfield Heights, Ohio, United States
Oklahoma Institute of Allergy and Asthma Clinical Research
Oklahoma City, Oklahoma, United States
Discovery Clinical Trials
Dallas, Texas, United States
Lysosomal Rare Disorders Research & Treatment Center
Fairfax, Virginia, United States
Time frame: Up to approximately 7 months
Adverse Reactions
Number and incidence of adverse reactions plus suspected adverse reactions combined
Time frame: Up to approximately 7 months
Related Adverse Reactions
Incidence of adverse infusion related reactions
Time frame: Up to approximately 7 months
Infusion Site Reactions
Incidence reactions occuring at the infusion site
Time frame: Up to approximately 7 months
Vital Signs
Change in vital signs
Time frame: 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
Time frame: Up to 72 hours after each infusion through study completion, up tp approximately 7 months
Total IgG Trough
Levels taken before any infusion
Time frame: At each visit through study completion, up tp approximately 7 months
IgG subclasses
Levels of subclasses 1- 4 before infusion
Time frame: Prior to first and last infusion, up tp approximately 7 months
Total IgG Post
End of infusion level of Total IgG
Time frame: At each infusion through study completion, up tp approximately 7 months
Cmax
Pharmacokinetic measure at 5th or 7th infusion
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to approximately 7 months
First Serious Bacterial Infection
Time to first Serious Bacterial Infections in days
Time frame: Up to approximately 7 months
Serious Bacterial Infections
Incidence of Serious Bacterial Infections
Time frame: Up to approximately 7 months
Other Infections
Incidence of infections other than Serious Bacterial Infections
Time frame: Up to approximately 7 months
Resolution of Infections
Time to resolution of Infections in days
Time frame: Up to approximately 7 months
Fever
Episodes of Fever
Time frame: Up to approximately 7 months
Missed Days
Number of days missed of school or work due to infections and treatment
Time frame: Up to approximately 7 months
Hospitalizations
Number of hospitalizations due to infections
Time frame: Up to approximately 7 months
Terminal phase elimination rate (λZ)
Pharmacokinetic measure at 5th or 7th infusion
Time frame: 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