ong Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Conditions: Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 18.0Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2011-000443-24-DK

Lead Sponsor: Insmed Incorporated

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 250

Inclusion Criteria

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

Exclusion Criteria

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