A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency

Trial Profile

A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency

Recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Oct 2017

At a glance

  • Drugs Liprotamase (Primary)
  • Indications Cystic fibrosis; Exocrine pancreatic insufficiency
  • Focus Registrational; Therapeutic Use
  • Acronyms RESULT
  • Sponsors Anthera Pharmaceuticals
  • Most Recent Events

    • 07 Sep 2017 According to an Anthera Pharmaceuticals media release, more than 50% of the anticipated patients needed to complete enrollment have entered screening for the RESULT trial.
    • 14 Aug 2017 According to an Anthera Pharmaceuticals media release, this study has been approved by the European Cystic Fibrosis Society Clinical Trial Network (ECFS CTN) Executive Committee.
    • 09 Aug 2017 According to an Anthera Pharmaceuticals media release, the company currently plans to conduct an interim futility analysis toward the end of the third quarter or beginning of the fourth quarter of 2017. Topline data is expected at the end of 2017 or early 2018.
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