Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
APT Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00633373
First received: March 5, 2008
Last updated: September 13, 2012
Last verified: September 2012

March 5, 2008
September 13, 2012
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00633373 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients
An Open-label Treatment Use Protocol of Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients

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.

Not Provided
Expanded Access
Not Provided
Not Provided
Lung Transplant
Drug: Cyclosporine Inhalation Solution
Cyclosporine USP Inhalation Solution (CIS) 300mg/4.8 mL delivered via a disposable nebulizer. A titration phase of 10 days is recommended starting with 100 mg and then increasing over the 10 days to a maximum of 300 mg or the highest tolerated dose.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
No longer available
Not Provided
Not Provided
Not Provided

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Known hypersensitivity to cyclosporine or propylene glycol (PG)
  • Females who are pregnant or are considering becoming pregnant
  • Females who are breast feeding a child.
Both
Not Provided
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00633373
ACS004
Not Provided
APT Pharmaceuticals, Inc.
APT Pharmaceuticals, Inc.
Not Provided
Not Provided
APT Pharmaceuticals, Inc.
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP