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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bivigam | Patients with primary immunodeficiency disease treated with Bivigam™ |
| |
| Other IGIV | Patients with primary immunodeficiency disease treated with other IGIVs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bivigam | Biological | Human immune globulin |
| |
| Other |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During infusion and up to 72 hours post infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Throughout the duration of study participation, up to approximately 140 days. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with primary immunodeficiency disease treated IGIV products.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Barbara Specialty Pharmacy | Carpinteria | California | 93013 | United States | ||
| Allergy and Asthma of the Bay Area |
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| Biological |
Human immune globulin |
|
| 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. | 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. | Throughout the duration of study participation, up to approximately 140 days. |
| Walnut Creek |
| California |
| 94598 |
| United States |
| Immunoe Research Centers | Centennial | Colorado | 80112 | United States |
| Central Georgia Infectious Disease Consultants | Macon | Georgia | 31201 | United States |
| Midwest Allergy and Sinus | Normal | Illinois | 61761 | United States |
| Kanarek Adult & Pediatric Allergy & Immunology | Overland Park | Kansas | 66211 | United States |
| Infectious Disease Consultants | Wichita | Kansas | 67211 | United States |
| The Center for Allergy, Asthma & Immunology | Syosset | New York | 11234 | United States |
| Allergy Asthma & Immunology Relief | Charlotte | North Carolina | 28204 | United States |
| Ohio Clinical Research Associates | Mayfield Heights | Ohio | 44124 | United States |
| Oklahoma Institute of Allergy and Asthma Clinical Research | Oklahoma City | Oklahoma | 73131 | United States |
| Austin Infectious Disease Consultants | Austin | Texas | 78705 | United States |
| Discovery Clinical Trials | Dallas | Texas | 75225 | United States |
| Allergy Partners of North Texas | Dallas | Texas | 75230 | United States |
| Allergy Immunology and Respiratory Care | Dallas | Texas | 75231 | United States |
| University of Texas Southwestern Medical Center | Irving | Texas | 75390 | United States |
| Lysosomal Rare Disorders Research & Treatment Center | Fairfax | Virginia | 22030 | United States |
| ID | Term |
|---|---|
| D000081207 | Primary Immunodeficiency Diseases |
| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| ID | Term |
|---|---|
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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