This is a safety study to evaluate the risk of low blood pressure in subjects with Primary Immune Deficiency disorder (PID) treated with Bivigam™ or another commercial product under real world conditions. No study medication will be provided to subjects in this study. Study physicians will make all treatment decisions according to their usual practice and will provide prescriptions for his/her subjects, as appropriate. The only addition is the collection and structured documentation of data generated through usual practice.
Study Type
OBSERVATIONAL
Enrollment
200
Human immune globulin
Human immune globulin
Santa Barbara Specialty Pharmacy
Carpinteria, California, United States
Allergy and Asthma of the Bay Area
Walnut Creek, California, United States
Immunoe Research Centers
Centennial, Colorado, United States
Central Georgia Infectious Disease Consultants
Macon, Georgia, United States
Midwest Allergy and Sinus
Normal, Illinois, United States
Kanarek Adult & Pediatric Allergy & Immunology
Overland Park, Kansas, United States
Infectious Disease Consultants
Wichita, Kansas, United States
The Center for Allergy, Asthma & Immunology
Syosset, New York, United States
Allergy Asthma & Immunology Relief
Charlotte, North Carolina, United States
Ohio Clinical Research Associates
Mayfield Heights, Ohio, United States
...and 7 more locations
Rate of Hypotension
The number of events of hypotension in subjects treated with Bivigam or other immune globulin intravenous (IGIV) products. Hypotension is defined as a systolic decrease of 30mmHG or a systolic blood pressure less than 90mmHG and clinical symptoms of hypotension including 1 or more of the following: dizziness, light-headedness, fainting (syncope), chest pain, or diaphoresis.
Time frame: During infusion and up to 72 hours post infusion.
Rate of Hepatic Impairment
The number of events of hepatic impairment in subjects treated with Bivigam or other immune globulin intravenous products. The criterion for defining hepatic impairment is transaminases three times the upper limit of normal evaluated based upon medical history, treatment history and the presence of co-morbid conditions.
Time frame: Throughout the duration of study participation, up to approximately 140 days.
Rate of Renal Impairment
The number of events of renal impairment in subjects treated with Bivigam or other immune globulin intravenous. The criterion for defining hepatic impairment is creatinine values greater than three times the upper limit of normal evaluated based upon medical history, treatment history and the presence of co-morbid conditions.
Time frame: Throughout the duration of study participation, up to approximately 140 days.
Rates of Other Adverse Events
The rates of other adverse events in patients treated with Bivigam™ or other immune globulin intravenous products.
Time frame: Throughout the duration of study participation, up to approximately 140 days.
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