CIS001 Extension Study of Cyclosporine Inhalation Solution (CIS002)

This study has been terminated.

(Parent study CIS001 was completed)

Sponsor:

Information provided by (Responsible Party):

APT Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT00938236

First received: July 9, 2009

Last updated: September 13, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 9, 2009

Last Updated Date

September 13, 2012

Start Date ^ICMJE

December 2009

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00938236 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

CIS001 Extension Study of Cyclosporine Inhalation Solution

Official Title ^ICMJE

CIS002: An Open-Label, Multi-Center, Extension Study of Cyclosporine Inhalation Solution in Subjects Previously Enrolled in the APT Study CIS001

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Lung Transplant

Intervention ^ICMJE

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

Study Arm (s)

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)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

December 2011

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00938236

Other Study ID Numbers ^ICMJE

CIS002

Has Data Monitoring Committee

Yes

Responsible Party

APT Pharmaceuticals, Inc.

Study Sponsor ^ICMJE

APT Pharmaceuticals, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Bruce A Johnson, MD	University of Pittsburgh
Principal Investigator:	Jeffrey Golden, MD	University of California, San Francisco

Information Provided By

APT Pharmaceuticals, Inc.

Verification Date

September 2012

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

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