Open-label Safety Extension Study Assessing Safety and Tolerability of LAI in Patients Who Participated in Study INS-212



Status:Enrolling by invitation
Healthy:No
Age Range:18 - Any
Updated:6/16/2016
Start Date:December 2015

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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.


Key Inclusion Criteria:

1. have successfully completed the Month 6 and End of Treatment visits in Study INS-212

2. 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
We found this trial at
12
sites
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mi
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Tampa, FL
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Charleston, South Carolina 29412
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from
Charleston, SC
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Charlotte, North Carolina 28207
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from
Charlotte, NC
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from
Chermside,
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from
Clermont, FL
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Huntersville, North Carolina 28078
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from
Huntersville, NC
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from
New York, NY
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from
Philadelphia, PA
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from
Portland, OR
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from
Springfield, IL
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from
Tyler, TX
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from
Washington DC, MD
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