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Study Name: Long term study of Arikace in people with CF with Chronic Pseudomonas Aeruginosa Lung Infection
Study Type: Interventional
Intervention Category: Anti-Infective
Study Sponsor: Insmed
Study Phase: 3
Recruitment Status: Not Yet Recruiting
Study Drug(s): Arikace
Number of Participants Being Recruited: 500
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
The total study period will be up to 96 weeks (approximately 2 years). It will be done as two consecutive extension periods, each consisting of 48 weeks (approximately 12 months). Eligible participants will be re-consented before participating in the second extension period at the completion of the first extension period. Arikace will be taken on a cyclic basis (28 days on and 28 days off) and seen at different time periods in clinic.
ELIGIBILITY
Age: >= 6 Years
FEV1: >= 25 Percent Predicted
P. aeruginosa status: Positive
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

To participate in this open-label extension study a subject must have completed either of the other 2 phase 3 studies of Arikace (TR02-108 or TR02-109).
Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
FOR MORE INFORMATION:
Sponsor Contact Information: Gupta, Renu
(732) 997-4526
rgupta@transaveinc.com
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/ct2/show/NCT01316276?term=insmed+and+cystic+fibrosis&rank=2
Clinical Research Terms Glossary: Click here
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