CIS001 Extension Study of Cyclosporine Inhalation Solution

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00938236
• Date of registration: 09/07/2009
• Primary sponsor: APT Pharmaceuticals, Inc.
• Public title: CIS001 Extension Study of Cyclosporine Inhalation Solution CIS002
• Scientific title: CIS002: An Open-Label, Multi-Center, Extension Study of Cyclosporine Inhalation Solution in Subjects Previously Enrolled in the APT Study CIS001
• Date of first enrolment: December 2009
• Target sample size: 17
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00938236
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Countries of recruitment

Canada, United States

Contacts

• Name: Jeffrey Golden, MD
• Affiliation: University of California, San Francisco

• Name: Bruce A Johnson, MD
• Affiliation: University of Pittsburgh

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lung Transplant

Intervention(s)

Drug: Cyclosporine Inhalation Solution (CIS)

Primary Outcome(s)

To assess the long-term safety of CIS administration [Time Frame: 5 years]

Secondary ID(s)

CIS002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors