EUCTR2018-000240-26-GB进行中（未招募）1 期
An open-label, pilot study to assess safety, tolerability, pharmacokinetics and effects of inhaled PC945 in the pre-emptive treatment of Aspergillus fumigatus colonisation in lung transplant recipients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Surveillance Phase:
- •1. Between the ages of 18 and 85 years.
- •2. Received a single or bilateral lung transplant.
- •3. Provided written informed consent prior to transplant.
- •Pre-emptive treatment phase:
- •1. A positive test for A. fumigatus in BAL during the Surveillance Phase of the study
- •2. Provided written informed consent for participating in the Pre-Emptive Treatment Phase.
- •Follow-up Phase:
- •1. Subject is not eligible to receive pre-emptive PC945 treatment due to either clinical, endobronchial and/or radiological features of fungal disease OR a fungal infection other than A. fumigatus in BAL, that requires SoC antifungal treatment to be started during the Surveillance Phase of the study.
- •2. Provided written informed consent for participating in the follow-up phase for SoC antifungal treatment.
- •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 25
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Surveillance Phase:
- •1. Is precluded from participating in this study as a result of treatment with another investigational drug or participation in another clinical trial.
- •2. If female, the subject is pregnant, lactating or breast feeding.
- •3. Any other clinically significant disease or condition, which in the Investigator’s medical opinion would preclude the subject’s participation in a clinical trial (e.g., recent myocardial infarction).
- •4. Is employed or is a first-degree relative of anyone employed by Pulmocide, a participating clinical trial site, or any contract research organisation involved in the study.
- •5. Is receiving antiretroviral protease inhibitor therapy.
- •6. Has human immunodeficiency virus or chronic, active hepatitis infection, or had a positive hepatitis B surface antigen or hepatitis C virus RNA test prior to transplant.
- •7. Any known history or current evidence of alcohol or drug abuse that, in the Investigator’s opinion, would exclude the subject from participation in the study.
- •Pre-emptive Treatment Phase:
- •1. Clinical, endobronchial and/or radiological features of fungal disease.
- •2. Any other disease or condition, which in the Investigator’s medical opinion would preclude the subject’s participation in the Pre-Emptive Treatment Phase of the study (e.g., recent myocardial infarction).
- •Follow-up Phase:
- •1. Any other disease or condition, which in the Investigator’s medical opinion would preclude the subject’s participation in the follow-up phase for SoC antifungal treatment.
研究者
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