NCT00633373No Longer Available不适用
An Open-label Treatment Use Protocol of Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients
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
- 否
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
研究点 (8)
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