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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: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 17 Oct 2019

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At a glance

  • Drugs Lipase (Primary)
  • Indications Exocrine pancreatic insufficiency
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms OPTION
  • Sponsors AzurRx BioPharma
  • Most Recent Events

    • 17 Oct 2019 According to an AzurRx BioPharma media release, the positive safety review of the CFF DSMB supports the company's plan to proceed to a higher 4-gram dose of MS1819-SD in its next planned Phase 2 clinical trial.
    • 17 Oct 2019 Results published in the AzurRx BioPharma Media Release.
    • 17 Oct 2019 According to an AzurRx BioPharma media release, the company announced that the Cystic Fibrosis Foundation (CFF) Data Safety Monitoring Board (DSMB) has completed its review of the final results of the Phase 2 OPTION trial and has found no safety concerns for MS1819-SD.
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