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A Phase 2, Open-Label, Multicenter, 2x2 Crossover Trial to Assess the Safety and Efficacy of MS1819-SD in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

Trial Profile

A Phase 2, Open-Label, Multicenter, 2x2 Crossover Trial to Assess the Safety and Efficacy of MS1819-SD in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 16 Feb 2023

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At a glance

  • Drugs Adrulipase alfa (Primary)
  • Indications Exocrine pancreatic insufficiency
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms OPTION
  • Sponsors First Wave Bio
  • Most Recent Events

    • 15 Sep 2020 According to an AzurRx BioPharma media release, results From this trial will be presented at the North American Cystic Fibrosis Conference (NACFC) 2020. The abstracts will be showcased in the NACFC virtual poster gallery and electronically published as a supplement to Pediatric Pulmonology.
    • 19 May 2020 Results published in Gastroenterology in conjunction with Digestive Disease Week 2020
    • 19 Feb 2020 Status changed from active, no longer recruiting to completed.
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