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Phase 3 extension study in patients with lung infections (INS-312).

  • Research type

    Research Study

  • Full title

    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.

  • IRAS ID

    190666

  • Contact name

    Charles Haworth

  • Contact email

    charles.haworth@papworth.nhs.uk

  • Sponsor organisation

    Insmed Inc.

  • Eudract number

    2015-003170-33

  • Duration of Study in the UK

    1 years, 10 months, 0 days

  • Research summary

    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.

  • REC name

    East of England - Cambridge East Research Ethics Committee

  • REC reference

    15/EE/0446

  • Date of REC Opinion

    29 Feb 2016

  • REC opinion

    Further Information Favourable Opinion