NCT00938236终止3 期
CIS002: An Open-Label, Multi-Center, Extension Study of Cyclosporine Inhalation Solution in Subjects Previously Enrolled in the APT Study CIS001
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 16
- 主要终点
- To assess the long-term safety of CIS administration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrollment in study CIS001
- •Written informed consent for CIS002
- •Use of an effective means of contraception by women of childbearing potential
排除标准
- •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.
研究组 & 干预措施
Inhaled cyclosporine
Other
Extended access to inhaled cyclosporine for patients from treatment and control arms of Phase 3 study CIS001
干预措施: Cyclosporine Inhalation Solution (CIS) (Drug)
结局指标
主要结局
To assess the long-term safety of CIS administration
时间窗: 5 years
次要结局
未报告次要终点
研究者
研究点 (16)
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