EUCTR2011-000443-24-DK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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