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
74
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 objective of the study is to demonstrate the efficacy of the IMP by determining that the mean annual acute SBI rate (as defined in Appendix 20.1) is statistically significantly lower than one infection per subject per year.
Time frame: 1 year
Immunoglobulin G (IgG) trough concentration
The average serum total IgG trough concentrations prior to each infusion
Time frame: up to 12 months per subject
Days unable to perform daily activities
The number of days unable to perform daily activities
Time frame: up to 12 months per subject
Therapeutic IgG levels
The ability of the IMP to maintain stable, therapeutic IgG levels
Time frame: up to 12 months per subject
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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