A Phase 3, Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency

Trial Profile

A Phase 3, Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency

Completed
Phase of Trial: Phase III

Latest Information Update: 27 May 2017

At a glance

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

    • 19 May 2017 Status changed from recruiting to completed.
    • 27 Feb 2017 According to an Anthera Pharmaceuticals media release, after completing this study patients will have an option to enroll into a phase IV, EASY study (profile 700274144).
    • 27 Feb 2017 According to an Anthera Pharmaceuticals media release, based on the data from the SOLUTION study (profile 250916), the company plans to amend this study to follow a similar dosing paradigm as the RESULT (profile 280130) study.
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