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Sponsored by: |
APT Pharmaceuticals, Inc. |
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Information provided by: | APT Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00633373 |
Currently there are no approved therapies for lung transplant recipients in the United States (US). Treatment with CIS following lung transplantation has previously been demonstrated to result in a clinically meaningful improvement in survival and chronic rejection-free survival compared to placebo, but additional data supporting its use is needed prior to Food and Drug Administration (FDA) approval. This treatment use protocol is a mechanism for providing eligible lung transplant recipients early access to CIS in advance of FDA approval.
Condition | Intervention |
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Lung Transplant |
Drug: Cyclosporine Inhalation Solution |
Study Type: | Expanded Access |
Official Title: | An Open-Label Treatment Use Protocol of Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Contact: Charles Johnson, MB, ChB | 650-483-9531 | charliej@aptbio.com |
Contact: Wendy Verret, MPH | 650-931-1666 ext 117 | wverret@aptbio.com |
United States, California | |
University of California at San Francisco | |
San Francisco, California, United States, 94143 | |
United States, Florida | |
University of Florida Health Sciences Center | |
Gainesville, Florida, United States, 32610 | |
Tampa General Hospital | |
Tampa, Florida, United States, 33601 | |
United States, Maryland | |
University of Maryland Medical Center | |
Baltimore, Maryland, United States, 21201 | |
United States, Massachusetts | |
Children's Hospital Boston | |
Boston, Massachusetts, United States, 02115 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | |
Pittsburgh, Pennsylvania, United States, 15213 |
Responsible Party: | APT Pharmaceutical Inc. ( Charles Johnson, MB. ChB. ) |
Study ID Numbers: | ACS004 |
Study First Received: | March 5, 2008 |
Last Updated: | February 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00633373 History of Changes |
Health Authority: | United States: Food and Drug Administration |
lung transplant transplant rejection |
Cyclosporine bronchiolitis obliterans aerosol |
Anti-Infective Agents Cyclosporine Immunologic Factors Antifungal Agents Bronchiolitis |
Antirheumatic Agents Immunosuppressive Agents Cyclosporins Bronchiolitis Obliterans |
Anti-Infective Agents Cyclosporine Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs Enzyme Inhibitors Cyclosporins |
Immunosuppressive Agents Pharmacologic Actions Antifungal Agents Therapeutic Uses Antirheumatic Agents Dermatologic Agents |