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 |
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.
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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