EUCTR2011-000443-24-IT进行中（未招募）不适用
ong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
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
- •1) Written informed consent or assent obtained from the subject, parent or legal guardian to participate in the open label multi-cycle study, TR02- 110 2) Subject has completed study TR02-108 or TR02-109, and has been compliant with the study protocol 3) Negative pregnancy result on pregnancy test performed within 2 weeks prior to Day 1 and use of reliable methods of contraception (e.g., abstinence, hormonal or barrier methods, partner sterilization, or IUD) throughout the study duration in women of child-bearing potential. Women not of childbearing potential are defined as prepubescent, postmenopausal (i.e., amenorrhea for at least 1 year), or surgically or naturally sterile
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Subject met any of the listed criteria for study drug discontinuation (safety reasons or non-compliance) in protocol TR02-108 or TR02-109 2) Elevated AST, ALT or GGT = 3× the upper limit of normal (ULN) within 4 weeks prior to Day 1 3) Absolute neutrophil count < 1000 within 4 weeks prior to Day 1 4) Serum creatinine > 2× ULN within 4 weeks prior to Day 1 5) Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements. 6) History of alcohol, medication, or illicit drug abuse within the 6 months prior to consent 7) Smoking tobacco or any substance within 6 months prior to consent or anticipated inability to refrain from smoking throughout the study 8) Any condition which in the opinion of the investigator interferes with the subject's ability to safely complete the study or adhere to the study requirements
研究者
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