NCT02095626已完成2 期
Pilot Study to Investigate the Clinical Effect of Orally Inhaled AP301 on Treatment of Primary Graft Dysfunction (PGD) in Mechanically Ventilated Patients After Primary Lung Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- P/F ratio
研究概览
简要总结
The purpose of this study is to investigate the effect of orally inhaled AP-301 on primary graft dysfunction after lung transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Being a male or female recipient on the AKH's waiting list for primary single or double LuTX
- •PGD score ≥ 1 within 72 hours after LuTX
- •Informed consent is available
排除标准
- •History of clinically relevant allergies or idiosyncrasies to AP301 or any other inactive ingredient(s) of the investigational product
- •Postoperative ECMO support
- •Paediatric /adolescent recipients (< 18 years)
- •Lobar transplantation
- •Retransplantation
- •Combined solid organ transplants
- •Participation in other drug trials
研究组 & 干预措施
AP301
Experimental
Treatment group
干预措施: AP-301 (Drug)
Saline solution
Placebo Comparator
干预措施: saline solution (Drug)
结局指标
主要结局
P/F ratio
时间窗: 7 days
The changes of the P/F ratio from T0 (time of PGD diagnosis) to day 7 of the treatment or to extubation of the patient
次要结局
- EVLW(7 days or until extubation)
研究者
研究点 (1)
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