Phase 3 extension study in patients with lung infections (INS-312).
An Open-Label Safety Extension Study to a Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) that are refractory to treatment.
Duration of Study in the UK
1 years, 10 months, 0 days
This open-label safety extension study will assess safety and tolerability of once daily dosing of 590 mg Liposomal Amakacin for Inhalation (LAI) added to a multi-drug regimen in subjects with Non-Tuberculous Mycobacterial (NTM) lung infections due to Mycobacterium avium complex (MAC) who are refractory to therapy. Eligible subjects will have successfully completed their Month 6 visit in the INS-212 study and confirmed to have not achieved the INS-212 protocol definition of culture conversion (3 consecutive negative sputum cultures) or have had a relapse or recurrence (agar positive or more than 2 consecutive broth positive results after culture conversion has occurred) by Month 6; eligible subjects would subsequently also have successfully completed their EOT visit in the INS-212 study.
Sputum samples collected up to and including Month 6 in the INS-212 study will be used to determine eligibility of the subject. All subjects will continue on their multi-drug anti-mycobacterial regimen that they were receiving (either alone or plus 590 mg LAI) during the INS-212 study and will receive LAI 590 mg QD for 12 months.
East of England - Cambridge East Research Ethics Committee
Date of REC Opinion
29 Feb 2016
Further Information Favourable Opinion