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Sponsor decided not to go forward with study for FDA submission.
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To compare the performance of the QuantiFERON Monitor assay against existing methodology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solid Organ Transplant Recipients | Subjects who have received a Solid Organ Transplant. |
| |
| Healthy Controls | Healthy individuals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QuantiFERON Monitor Assay | Device | Assay to measure cell-mediated immune function using QuantiFERON Monitor assay. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cell-mediated immune response. | 1 day (At time of enrollment) |
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Solid Organ Transplant Recipient
Inclusion Criteria:
Exclusion Criteria:
Healthy Control
Inclusion Criteria:
Exclusion Criteria:
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Subjects who have either received a solid organ transplant or who are healthy.
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| Name | Affiliation | Role |
|---|---|---|
| Camille N Kotton, M.D. | Transplant and Immunocompromised Host Infectious Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles | Los Angeles | California | 90024 | United States | ||
| Massachusetts General Hospital |
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| Existing methodology | Device | Assay to measure cell-mediated immune function using existing methodology. |
|
| Boston |
| Massachusetts |
| 02114 |
| United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |