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An Open-label, Non-controlled, Multicenter, Pilot Trial, Using Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial (NTM) Infection

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Trial Profile

An Open-label, Non-controlled, Multicenter, Pilot Trial, Using Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial (NTM) Infection

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 29 Oct 2021

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At a glance

  • Drugs Molgramostim (Primary)
  • Indications Mycobacterial infections; Mycobacterium avium complex infections; Nontuberculous mycobacterium infections
  • Focus Therapeutic Use
  • Acronyms ENCORE
  • Sponsors Savara Pharmaceuticals

Most Recent Events

  • 13 Sep 2021 Number of treatment arms have been increased from 1 to 3 by the addition of two more groups, thus comprising 3 groups namely negative culture, positive culture and those not meeting recommendations for treatment with a multidrug NTM guideline-based antimycobacterial regimen. Intervention model is changed from single-group assignment to parallel assignment.
  • 03 Sep 2020 Results presented in the Savara Pharmaceuticals Media Release.
  • 03 Sep 2020 According to an Savara Pharmaceuticals media release, the decision to discontinue the study was not based on safety concerns.

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