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

Insmed Incorporated0 个研究点目标入组 250 人开始时间: 2011年5月25日最近更新: 2016年8月22日

适应症

试验速览

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•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: 4
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 14
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 3

•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

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