Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients
- Conditions
- Lung Transplant
- Registration Number
- NCT00633373
- Lead Sponsor
- APT Pharmaceuticals, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
- Single-or double-lung transplant recipients who have a high risk for developing chronic rejection
- Single or double-lung transplant recipients who have developed chronic rejection
- Single or double-lung transplant recipients who have serious or life-threatening complications of systemic immunosuppressive therapy
- Known hypersensitivity to cyclosporine or propylene glycol (PG)
- Females who are pregnant or are considering becoming pregnant
- Females who are breast feeding a child.
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University of California at San Francisco
🇺🇸San Francisco, California, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Baylor Clinic, Baylor College of Medicine
🇺🇸Houston, Texas, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Children's Hospital Boston
🇺🇸Boston, Massachusetts, United States
University of Florida Health Sciences Center
🇺🇸Gainesville, Florida, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States