CIS001 Extension Study of Cyclosporine Inhalation Solution (CIS002)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00938236
Recruitment Status : Terminated (Parent study CIS001 was completed)
First Posted : July 13, 2009
Last Update Posted : September 17, 2012
Information provided by (Responsible Party):
APT Pharmaceuticals, Inc.

July 9, 2009
July 13, 2009
September 17, 2012
December 2009
September 2011   (Final data collection date for primary outcome measure)
To assess the long-term safety of CIS administration [ Time Frame: 5 years ]
Same as current
Complete list of historical versions of study NCT00938236 on Archive Site
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CIS001 Extension Study of Cyclosporine Inhalation Solution
CIS002: An Open-Label, Multi-Center, Extension Study of Cyclosporine Inhalation Solution in Subjects Previously Enrolled in the APT Study CIS001
This trial is a longterm follow up of a phase III study of inhaled cyclosporine for the prevention of chronic rejection in lung transplant recipients.
Not Provided
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Lung Transplant
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
Inhaled cyclosporine
Extended access to inhaled cyclosporine for patients from treatment and control arms of Phase 3 study CIS001
Intervention: Drug: Cyclosporine Inhalation Solution (CIS)

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2011
September 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Enrollment in study CIS001
  2. Written informed consent for CIS002
  3. Use of an effective means of contraception by women of childbearing potential

Exclusion Criteria:

  1. Any unresolved or irreversible CIS-related ongoing serious adverse event
  2. Subjects who have developed newly emergent conditions, injuries, diagnoses, physical examination findings, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk of treatment complications
  3. Subjects with suspected or documented allergy to propylene glycol and/or cyclosporine
  4. Women who are pregnant, wishing to become pregnant, or unwilling to use appropriate birth control to avoid becoming pregnant
  5. Women who are breastfeeding
  6. Subjects unable to comply with all protocol requirements and follow-up procedures
  7. Subjects who discontinued from CIS002 to participate in another clinical trial and have received any investigational treatment (other than CIS) within 14 days of titration visit 1/baseline.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
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APT Pharmaceuticals, Inc.
APT Pharmaceuticals, Inc.
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Principal Investigator: Bruce A Johnson, MD University of Pittsburgh
Principal Investigator: Jeffrey Golden, MD University of California, San Francisco
APT Pharmaceuticals, Inc.
September 2012

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