A Randomized, Open Label, 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

Trial Profile

A Randomized, Open Label, 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

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Sep 2017

At a glance

  • Drugs Amikacin (Primary)
  • Indications Mycobacterium avium complex infections; Respiratory tract infections
  • Focus Registrational; Therapeutic Use
  • Acronyms CONVERT
  • Sponsors Insmed
  • Most Recent Events

    • 05 Sep 2017 David Griffith is Principal Investigator in the CONVERT study, as reported in an Insmed media release
    • 05 Sep 2017 The company plans to pursue accelerated approval of ALIS under subpart H based on the data from this trial which will be reviewed by the Division of Anti-Infective Products, as reported in an Insmed media release.
    • 05 Sep 2017 Primary endpoint has been met. (Proportion of patients achieving culture conversion in the LAI plus a multi-drug regimen arm compared to a multi-drug regimen alone with no relapse or recurrence), as reported in an Insmed media release.
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