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| Name | Class |
|---|---|
| Bio Products Laboratory (BPL) | UNKNOWN |
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The purpose of this study is to demonstrate the utility of measuring outcomes in 5% treatment naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) patients using infusion nurse and patient measured physical, quality of life (QOL), respiratory, and disability assessments using CareExchange in the home setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gammaplex® IVIg |
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| Measure | Description | Time Frame |
|---|---|---|
| Analysis of collected data captured in CareExchange will demonstrate the ability to show and track changes in outcome data in 5% treatment naïve IVIg PIDD patients in the home setting. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the profile physician usage (dose and timing) with Gammaplex®. | 1 year | |
| Evaluate physician feedback to having real-time access to 5% treatment naïve IVIg PIDD data captured during home infusions. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Males and Females between 15-85 years of age with any form of PIDD who are considered 5% IVIg treatment naïve and whose physician has decided to prescribe Gammaplex® IVIg therapy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoag Medical Group (In Alliance with St. Joseph Heritage Healthcare) | Newport Beach | California | 92663 | United States | ||
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| Evaluate the safety profile of using a 5% treatment naïve IVIg in PIDD patients in the home setting. | 1 year |
| Demonstration of response rate for those receiving IVIg therapies. | 1 year |
| Demonstration of changes in outcomes as a result of changes made in IVIg dose and frequency during study participation. | 1 year |
| Demonstration of measured variables within patients who receive IVIg therapies. | 1 year |
| Evaluate the effectiveness of whether CareExchange leads to better QOLs and overall patient reported outcomes. | 1 year |
| Other potential impacts on change in outcomes across patient demographics (age, sex, race, ethnicity, etc.). | 1 year |
| IMMUNEOe International Research Centers |
| Centennial |
| Colorado |
| 80122 |
| United States |
| Atlanta ENT | Atlanta | Georgia | 30342 | United States |
| AxelaCare Health Solutions, LLC | Lenexa | Kansas | 66219 | 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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