Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikayce) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Trial Profile

Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikayce) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Sep 2017

At a glance

  • Drugs Amikacin (Primary)
  • Indications Cystic fibrosis-associated respiratory tract infections; Pseudomonal infections
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms CLEAR-110
  • Sponsors Insmed
  • Most Recent Events

    • 29 Aug 2015 Status changed from active, no longer recruiting to completed, as reported by European Clinical Trials Database record.
    • 15 Feb 2015 Protocol has been been amended in treatment table as change of dose of Liposomal Amikacin from 560 mg to 590 mg.
    • 15 Feb 2015 Planned End Date changed from 1 May 2015 to 1 Jul 2015, as reported by ClinicalTrials.gov.
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