Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients

• Status: No longer available
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

Details

• Lead Sponsor: APT Pharmaceuticals, Inc.
• Treatments: Cyclosporine; Cyclosporins; Pharmaceutical Solutions

Criteria

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.