Overview

CIS001 Extension Study of Cyclosporine Inhalation Solution

Status:
Terminated

Trial end date:
2011-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

APT Pharmaceuticals, Inc.

Treatments:

Cyclosporine
Cyclosporins
Pharmaceutical Solutions

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.