Open-label Safety Extension Study Assessing Safety and Tolerability of LAI in Patients Who Participated in Study INS-212
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ClinicalTrials.gov Identifier: NCT02628600
Recruitment Status : Unknown
Verified September 2016 by Insmed Incorporated. Recruitment status was: Enrolling by invitation
This open-label safety extension study will assess the safety and tolerability of once daily dosing of 590 mg Liposomal Amikacin for Inhalation (LAI) added to a multi-drug regimen in subjects with non-tuberculous mycobacterium (NTM) lung infections due to Mycobacterium avium complex (MAC) who are refractory to therapy in Study INS-212.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Key Inclusion Criteria:
have successfully completed the Month 6 and End of Treatment visits in Study INS-212
have not achieved the INS-212 protocol definition of culture conversion by Month 6 in Study INS-212 OR have experienced a relapse or recurrence by Month 6 in Study INS-212.
Key Exclusion Criteria:
1. achieved culture conversion without relapse or recurrence in the Study INS-212 study by Month 6