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| Tracking Information | |||||||||
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| First Received Date ICMJE | March 5, 2008 | ||||||||
| Last Updated Date | October 14, 2009 | ||||||||
| Start Date ICMJE | |||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00633373 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients | ||||||||
| Official Title ICMJE | An Open-label Treatment Use Protocol of Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients | ||||||||
| 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. |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type ICMJE | Expanded Access | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE | Lung Transplant | ||||||||
| Intervention ICMJE | Drug: Cyclosporine Inhalation Solution | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Available | ||||||||
| Enrollment ICMJE | |||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | |||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00633373 | ||||||||
| Responsible Party | Charles Johnson, MB. ChB., APT Pharmaceutical Inc. | ||||||||
| Study ID Numbers ICMJE | ACS004 | ||||||||
| Study Sponsor ICMJE | APT Pharmaceuticals, Inc. | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | APT Pharmaceuticals, Inc. | ||||||||
| Verification Date | February 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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