NCT05238116
终止
3 期
A Double-blind, Randomized, Placebo-controlled Study to Assess the Safety and Efficacy of Nebulized PC945 When Added to Systemic Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)
概览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 85
- 试验地点
- 85
- 主要终点
- Number of Participants with Complete or Partial Overall Response
概览
简要总结
To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double Blind
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
- •Participant has proven or probable IPA according to the modified 2019 European Organization for Research and Treatment of Cancer/ Mycoses Study Group Education and Research Consortium (EORTC/MSGERC) consensus definitions or according to the 2010 International Society for Heart and Lung Transplantation (ISHLT) consensus statements for the definitions of infections in cardiothoracic transplant recipients.
- •Participant's IPA has failed to respond to adequate antifungal therapy.
排除标准
- •Participant with a known or suspected concomitant medical condition or post-surgery complication that, in the opinion of the Investigator, may jeopardize adherence to the protocol requirements or impede the accurate measurement of efficacy or may be an unacceptable additional risk to the Participant should he/she participate in the study.
- •Participant who has previously received PC
- •Participant with a known history of allergy, hypersensitivity, or any previous serious reaction to any component of the PC945 or placebo formulations.
- •Participant who has recently received, is receiving or due to receive at any time during the study, an investigational medicinal agent that does not have any regulatory approved indications. Subjects who are participating in any other trials e.g., Observational, diagnostic or using medications with an approved indication may be allowed to participate after consultation with the sponsor on an individual basis
研究组 & 干预措施
PC945
Experimental
PC945 dose, administered via nebulizer, twice daily
干预措施: PC945 (Drug)
Placebo
Placebo Comparator
PC945-placebo administered via nebulizer, twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Complete or Partial Overall Response
时间窗: up to 12 weeks (Day 84)
次要结局
- Time to Complete or Partial Overall Clinical Response(up to 12 weeks (Day 84))
研究者
研究点 (85)
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