Status:
TERMINATED
CIS001 Extension Study of Cyclosporine Inhalation Solution
Lead Sponsor:
APT Pharmaceuticals, Inc.
Conditions:
Lung Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- Enrollment in study CIS001
- Written informed consent for CIS002
- Use of an effective means of contraception by women of childbearing potential
Exclusion
- Any unresolved or irreversible CIS-related ongoing serious adverse event
- 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
- Subjects with suspected or documented allergy to propylene glycol and/or cyclosporine
- Women who are pregnant, wishing to become pregnant, or unwilling to use appropriate birth control to avoid becoming pregnant
- Women who are breastfeeding
- Subjects unable to comply with all protocol requirements and follow-up procedures
- 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.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00938236
Start Date
December 1 2009
End Date
December 1 2011
Last Update
September 17 2012
Active Locations (16)
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1
UCLA School of Medicine
Los Angeles, California, United States, 90095
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
Stanford University Medical Center
Stanford, California, United States, 94305
4
University of Colorado Health Sciences Cente
Denver, Colorado, United States, 80262