Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients

Description

Currently there are no approved therapies for lung transplant recipients in the United States (US). Treatment with CIS following lung transplantation has previously been demonstrated to result in a clinically meaningful improvement in survival and chronic rejection-free survival compared to placebo, but additional data supporting its use is needed prior to Food and Drug Administration (FDA) approval. This treatment use protocol is a mechanism for providing eligible lung transplant recipients early access to CIS in advance of FDA approval.

Study Start Date

Not specified

Estimated Completion Date

Not specified

Interventions

  • Drug: Cyclosporine Inhalation Solution

Specialties

  • Nursing: Pulmonology
  • Surgery: Transplantation
  • Pulmonology: Transplantation

MeSH Terms

  • Cyclosporine
  • Lung Transplantation

Study ID

APT Pharmaceuticals, Inc. -- ACS004

Status

Available

Trial ID

NCT00633373

Study Type

Expanded Access

Trial Phase

N/A

Enrollment Quota

Not Listed

Sponsor

APT Pharmaceuticals, Inc.

Inclusion Criteria

  • Single-or double-lung transplant recipients who have a high risk for developing chronic rejection
  • Single or double-lung transplant recipients who have developed chronic rejection
  • Single or double-lung transplant recipients who have serious or life-threatening complications of systemic immunosuppressive therapy

Exclusion Criteria

  • Known hypersensitivity to cyclosporine or propylene glycol (PG)
  • Females who are pregnant or are considering becoming pregnant
  • Females who are breast feeding a child.

Gender

Both

Ages

N/A

Accepts Healthy Volunteers

Not Listed

Study Locations and Contact Information (8)

Study Location Distance Name Phone Email
Children's Hospital Boston - Boston, Massachusetts 2.6 miles None None None
University of Maryland Medical Center - Baltimore, Maryland 358.9 miles None None None
University of Pittsburgh Medical Center - Pittsburgh, Pennsylvania 478.5 miles None None None
Cleveland Clinic - Cleveland, Ohio 544.9 miles None None None
University of Florida Health Sciences Center - Gainesville, Florida 1,081.3 miles None None None
Tampa General Hospital - Tampa, Florida 1,186.3 miles None None None
Baylor Clinic, Baylor College of Medicine - Houston, Texas 1,609.9 miles None None None
University of California at San Francisco - San Francisco, California 2,699.8 miles None None None

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