The purpose of this study is to demonstrate bioequivalence of IVIG-PEG with Gamunex-C (IVIG-C) at steady-state as determined by comparing total Immunoglobulin G (IgG) area under the concentration-time curve during the defined dosing interval (\[AUC0-τ\] either every 3 weeks \[AUC0-21 days\] or every 4 weeks \[AUC0-28 days\]) and maximum concentration in a dosing interval (Cmax) in participants diagnosed with primary humoral immunodeficiency (PI) currently receiving chronic IVIG replacement treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Intravenous infusion.
Intravenous infusion.
Alabama Allergy & Asthma Center
Birmingham, Alabama, United States
Allergy Associates of the Palm Beaches PA
North Palm Beach, Florida, United States
The South Bend Clinic Center for Research
South Bend, Indiana, United States
Institute for Asthma and Allergy
Chevy Chase, Maryland, United States
Washington University
St Louis, Missouri, United States
Optimed Research, LLC
Columbus, Ohio, United States
Allergy, Asthma and Immunology Center, P.C.
Tulsa, Oklahoma, United States
Allergy Partners of North Texas Research
Dallas, Texas, United States
AARA Research Center
Dallas, Texas, United States
Allergy, Asthma & Immunology Clinic, P.A.
Irving, Texas, United States
AUC (0-7): Area Under the Concentration Time Curve Over a Dosing Interval of Either Every 3 Weeks [AUC0-21 Days] or Every 4 Weeks [AUC0-28 Days] for Total Immunoglobulin G (IgG)
AUC (0-7 days) is calculated as AUC (0-21 days)/3 for subjects with a dosing frequency of every 3 weeks and as AUC(0-28 days)/4 for subjects with a dosing frequency of every 4 weeks.
Time frame: Pre-dose, within 10 minutes of last infusion completion, at 1, 3, 6, 24, 48 hours and 4, 7, 14 and 21 days (up to 3 weeks), and 28 days (up to 4 weeks - only for subjects on a 4-week dosing schedule) post-infusion
Cmax: Maximum Concentration in a Dosing Interval for Total IgG
Time frame: Pre-dose, within 10 minutes of last infusion completion, at 1, 3, 6, 24, 48 hours, and 4, 7, 14, 21 and 28 days post-infusion (up to 4 weeks)
Rate of Serious Bacterial Infections (SBIs)
The rate of SBI events per participant per year during treatment was calculated as the total number of SBI events divided by the total duration of exposure in years across all participants. The 2-sided 98% confidence interval (CI) was determined from a generalized linear model for Poisson regression for the log-transformed number of events with log-transformed duration of exposure in years as an offset variable.
Time frame: Baseline up to 6 months for each period, i.e., overall GC treatment phase and overall IVIG-PEG treatment phase with an aggregate duration of up to 12 months
Rate of Events Per Participant Per Year in Participants With Any Kind of Infection
Rate of events per participant per year is calculated as the total number of events divided by the total duration of exposure in years across all participants. Any kind of infections included serious/nonserious including acute sinusitis, exacerbation of chronic sinusitis, acute otitis media, pneumonia, acute bronchitis, infectious diarrhea etc.) as determined by the Investigator.
Time frame: Baseline up to 6 months for each period, i.e., overall GC treatment phase and overall IVIG-PEG treatment phase with an aggregate duration of up to 12 months
Rate of Days Per Person Per Year That Participants Were on Antibiotics
Rate of days per person per year is calculated as the total number of days divided by the total duration of exposure in years across all participants. Antibiotics included prophylactic and therapeutic.
Time frame: Baseline up to 6 months for each period, i.e., overall GC treatment phase and overall IVIG-PEG treatment phase with an aggregate duration of up to 12 months
Number of Participants Hospitalized Due to Infection
Hospitalization was considered only in cases of hospital admission (including emergency room stay) for equal or more than 24 hours.
Time frame: Baseline up to 6 months for each period, i.e., overall GC treatment phase and overall IVIG-PEG treatment phase with an aggregate duration of up to 12 months
Rate of Days of Work/School/Daily Activities Missed Per Participant Due to Infections and Their Treatment
Rate of days per person per year is calculated as the total number of days divided by the total duration of exposure in years across all participants.
Time frame: Baseline up to 6 months for each period, i.e., overall GC treatment phase and overall IVIG-PEG treatment phase with an aggregate duration of up to 12 months
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