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临床试验/NCT00633373
NCT00633373No Longer Available不适用

An Open-label Treatment Use Protocol of Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients

APT Pharmaceuticals, Inc.8 个研究点 分布在 1 个国家开始时间: 2008年3月12日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
No Longer Available
试验地点
8

研究概览

简要总结

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.

研究设计

研究类型
Expanded Access

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (8)

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