CIS001 Extension Study of Cyclosporine Inhalation Solution

Stopped early · Phase 3

Conditions studied: Lung Transplant

In brief

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.

Key facts

Study ID

NCT00938236

Run by

APT Pharmaceuticals, Inc.

People needed

17

Starts

2009-12-01

Expected to finish

2011-12-01

Last updated by the study team

2012-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Enrollment in study CIS001
• Written informed consent for CIS002
• Use of an effective means of contraception by women of childbearing potential

You may not qualify if…

• 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.

Where it is running

• UCLA School of Medicine — Los Angeles, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Stanford University Medical Center — Stanford, California, United States
• University of Colorado Health Sciences Cente — Denver, Colorado, United States
• University of Florida Health Sciences Center — Gainesville, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Loyola University Hospital — Maywood, Illinois, United States
• Indiana Methodist Research Institute — Indianapolis, Indiana, United States
• University of Maryland — Baltimore, Maryland, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• New York Presbyterian Hospital, Columbia University Med. Ctr. — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States
• University of Toronto — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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