Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study Design:
This is a 2 arm non-interventional trial that will compare the occurrence of adverse drug reactions between Octagam 5% and other marketed IVIG infusion treatments.
This Post Marketing Study is a prospective, 2-armed, multicenter, non-interventional study. Patients will either be administered the brand of IGIV therapy ordered by their prescribing physician, or for patients issued unspecified or generic prescriptions of IGIV therapy, octagam® 5% or another brand of IGIV therapy will be provided by the Investigator according to federal, state and local regulations and good clinical practice (GCP) guidelines.
The primary objective is to assess and evaluate the safety profile of octagam® 5% during or after administration under routine clinical use for all labeled indications, with a special emphasis on the occurrence of TEEs. The incidence of TEEs in patients receiving octagam® 5% will be compared with the incidence rate in a matching concurrent control group of patients receiving other IGIVs for routine clinical use.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Octagam 5% | Primary Immune Deficiency Syndrome patients receiving Octagam 5% by infusion who have been treated with a marketed IVIG product for at least 6 months. |
| |
| Other marketed IVIG product | Primary Immune Deficiency Syndrome patients receiving marketed IVIG product other than Octagam 5% by infusion as treatment for at least 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octagam 5% | Biological | Intravenous immunoglobulin 5% |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Thromboembolytic events | 4 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients over 18 years old with Primary Immune Deficiency Syndrome PID receiving marketed IVIG as treatment
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Frenzel | International Medical Monitor, Octapharma AG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Octapharma Research Site | Granada Hills | California | 91344 | United States | ||
| Octapharma Research Site |
Not provided
Not provided
Not provided
Not provided
| Other marketed IVIG product |
| Biological |
Any intravenous immunoglobulin marketed product approved for the treatment of PID |
|
| Irvine |
| California |
| 92697 |
| United States |
| Octapharma Research Site | Los Angeles | California | 90025 | United States |
| Octapharma Research Site | Redlands | California | 92373 | United States |
| Octapharma Research Site | Centennial | Colorado | 80112 | United States |
| Octapharma Research Site | Roswell | Georgia | 30076 | United States |
| Octapharma Research Site | Chicago | Illinois | 60612 | United States |
| Octapharma Research Site | Springfield | Illinois | 62701 | United States |
| Octapharma Research Site | Fort Wayne | Indiana | 46815 | United States |
| Octapharma Research Site | Wichita | Kansas | 67201 | United States |
| Octapharma Research Site | Fort Mitchell | Kentucky | 41017 | United States |
| Octapharma Research Site | Farmington Hills | Michigan | 48334 | United States |
| Octapharma Research Site | Plymouth | Minnesota | 55446 | United States |
| Octapharma Research Site | Plymouth | Minnesota | 55447 | United States |
| Octapharma Research Site | Omaha | Nebraska | 68124 | United States |
| Octapharma Research Site | East Setauket | New York | 11733 | United States |
| Octapharma Research Site | New York | New York | 10012 | United States |
| Octapharma Research Site | New York | New York | 10065 | United States |
| Octapharma Research Site | Columbus | Ohio | 43235 | United States |
| Octapharma Research Site | Mayfield Heights | Ohio | 44124 | United States |
| Octapharma Research Site | Toledo | Ohio | 43617 | United States |
| Octapharma Research Site | Pawtucket | Rhode Island | 02860 | United States |
| Octapharma Research Site | Anderson | South Carolina | 29621 | United States |
| Octapharma Research Site | Nashville | Tennessee | 37203 | United States |
| Octapharma Research Site | Amarillo | Texas | 79124 | United States |
| Octapharma Research Site | Dallas | Texas | 75231 | United States |
| Octapharma Research Site | Irving | Texas | 75014 | 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 |
Not provided
Not provided