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A Phase III, Randomized, Double-blind, Placebo-controlled Study of AeroVanc for the Treatment of Persistent Methicillin-resistant Staphylococcus Aureus Lung Infection in Cystic Fibrosis Patients

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Trial Profile

A Phase III, Randomized, Double-blind, Placebo-controlled Study of AeroVanc for the Treatment of Persistent Methicillin-resistant Staphylococcus Aureus Lung Infection in Cystic Fibrosis Patients

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 10 Nov 2021

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At a glance

  • Drugs Vancomycin (Primary)
  • Indications Methicillin-resistant Staphylococcus aureus infections
  • Focus Registrational; Therapeutic Use
  • Acronyms AVAIL
  • Sponsors Savara Pharmaceuticals

    • Most Recent Events

    • 10 Dec 2020 According to a Savara Pharmaceuticals media release, based on the AVAIL results, the company is discontinuing further development of AeroVanc.
    • 10 Dec 2020 Primary endpoint (The mean absolute change from baseline in FEV1 percent predicted.The endpoint will be analyzed sequentially at week 12 (the end of cycle 2)) has not been met, according to a Savara Pharmaceuticals media release.
    • 10 Dec 2020 Primary endpoint (The mean absolute change from baseline in FEV1 percent predicted.The endpoint will be analyzed sequentially at Week 4 (end of Cycle 1) and at Week 20 (end of Cycle 3)) has not been met, according to a Savara Pharmaceuticals media release.

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