EUCTR2021-004554-32-GR招募中1 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)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 123
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. 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
- •2. Participant’s IPA has failed to respond to adequate antifungal therapy
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 95
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •1. 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 participates in the study.
- •2. Participant who has previously received PC945
- •3. Participant with a known history of allergy, hypersensitivity, or any previous serious reaction to any component of the PC945 or placebo formulations
- •4. Participants 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.
研究者
相似试验
进行中（未招募）
1 期
A study of UCB0942 in adult patients with highly drug-resistant focal epilepsyEUCTR2014-003330-12-HUCB Biopharma SPR46
进行中（未招募）
1 期
A study of UCB0942 in adult patients with highly drug-resistant focal epilepsyhighly drug-resistant focal epilepsyMedDRA version: 21.1Level: LLTClassification code 10065337Term: Focal epilepsySystem Organ Class: 100000004852EUCTR2014-003330-12-ITCB Biopharma SR55
招募中
1 期
Safety and efficacy of PC945 in combination with other antifungal therapy for the treatment of refractory invasive pulmonary aspergillosis (Opera-T Study)Refractory invasive pulmonary aspergillosis (IPA)MedDRA version: 20.0Level: LLTClassification code 10059259Term: Pulmonary aspergillosisSystem Organ Class: 10021881 - Infections and infestationsEUCTR2021-004554-32-ATPulmocide Ltd123
已完成
3 期
A double-blind, randomized, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P, CBD) as add-on therapy in patients with tuberous sclerosis complex who experience inadequately-controlled seizuresNL-OMON47292GW Research Ltd25
已完成
不适用
A double-blind, randomized, placebo-controlled study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending oral doses of ASP2905 in healthy young males, including an open-label two-period randomized crossover study to compare the pharmacokinetics under fasted and fed conditionsziekte van Alzheimer, schizofrenieAlzheimer's Disease and schizophrenyNL-OMON32022Astellas Pharma68