NL-OMON39469已完成3 期
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 - Arikace TR02-110
Chiltern International Ltd0 个研究点目标入组 3 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
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
- 年龄范围
- 18 至 99（—）
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
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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