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| Sponsored by: |
APT Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | APT Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00755781 |
Purpose
A Phase III, multi-center, randomized, controlled study designed to demonstrate the efficacy and safety of Cyclosporine Inhalation Solution (CIS)in improving survival and preventing bronchiolitis obliterans syndrome (BOS) when given prophylactically to lung transplant recipients in addition to their standard immunosuppressive regimen.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Transplant |
Drug: Cyclosporine Inhalation Solution (CIS) |
Phase III |
| Arms | Assigned Interventions |
|---|---|
|
CIS: Active Comparator
CIS in addition to standard immunosuppressive regimen.
|
Drug: Cyclosporine Inhalation Solution (CIS)
Cyclosporine (USP) Inhalation Solution; 300mg/4.8 mL in propylene glycol (USP) at a concentration of 62.5 mg/mL; 3 times a week for study duration (up to 3 years)
|
|
SOC: No Intervention
Standard of care (SOC) therapy for lung transplant recipients
|
Eligibility
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Charles Johnson, MB ChB | 650-931-1666 ext 127 | charliej@aptbio.com |
| Contact: Wendy Verret, MPH | 650-931-1666 ext 117 | wverret@aptbio.com |
| United States, California | |
| University of California, San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| UCLA School of Medicine | Not yet recruiting |
| Los Angeles, California, United States, 90095 | |
| Stanford University Medical Center | Recruiting |
| Stanford, California, United States, 94305 | |
| United States, Colorado | |
| University of Colorado Health Sciences Cente | Not yet recruiting |
| Denver, Colorado, United States, 80262 | |
| United States, Florida | |
| Tampa General Hospital | Recruiting |
| Tampa, Florida, United States, 33601 | |
| University of Florida Health Sciences Center | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| United States, Illinois | |
| Loyola University Hospital | Recruiting |
| Maywood, Illinois, United States, 60153 | |
| University of Chicago Hospitals | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| United States, Maryland | |
| University of Maryland | Not yet recruiting |
| Baltimore, Maryland, United States, 21201 | |
| United States, Minnesota | |
| University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, New York | |
| New York Presbyterian Hospital, Columbia University Med. Ctr. | Recruiting |
| New York, New York, United States, 10032 | |
| United States, Ohio | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Hospital of the University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| Baylor College of Medicine | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| Inova Fairfax Hospital | Recruiting |
| Falls Church, Virginia, United States, 22402 | |
| Canada, Ontario | |
| University of Toronto | Not yet recruiting |
| Toronto, Ontario, Canada, M5G 2N2 | |
| Study Director: | Charlies Johnson, MB ChB | APT Pharmaceuticals, Inc. |
More Information