The purpose of this study is to investigate the efficacy, safety, tolerability, and pharmacokinetic profile of the investigational medicinal product (IMP) and to determine, on the basis of historical control data, how it compares with other 10% intravenous immunoglobulin (IGIV) products currently licensed in North America for the treatment of subjects with primary immune deficiency diseases (PIDD).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
63
300-900 mg/kg
University of California
Los Angeles, California, United States
IMMUNOe Health & Research Centers
Centennial, Colorado, United States
University of South Florida
Tampa, Florida, United States
Mean Acute Serious Bacterial Infection (SBI) Rate
The primary efficacy endpoint was the rate of acute SBI (pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, visceral abscess) per participant during the 12-month study observation period
Time frame: 1 year
Immunoglobulin G (IgG) Trough Concentration
The average serum total IgG trough concentration
Time frame: Up to 1 year per participant
Days Unable to Perform Daily Activities
The number of days out of work/school/daycare or unable to perform normal daily activities due to infections
Time frame: Up to 1 year per participant
Therapeutic IgG Levels
Number of participants with maintenance of stable IgG levels
Time frame: Up to 1 year per participant
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Allergy Associates of the Palm Beaches, P.A.
West Palm Beach, Florida, United States
Institute for Asthma and Allergy, PC
Chevy Chase, Maryland, United States
Optimed Research Ltd.
Little Silver, New Jersey, United States
Optimed Research LTD
Columbus, Ohio, United States
Allergy Partners of North Texas
Dallas, Texas, United States
AARA Research Center
Dallas, Texas, United States
AAICPA
Irving, Texas, United States
...and 2 more locations