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

Discontinued
Phase of Trial: Phase III

Latest Information Update: 25 Apr 2018

At a glance

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

    • 21 Apr 2018 Planned number of patients changed from 140 to 150.
    • 12 Mar 2018 According to an Anthera Pharmaceuticals media release, the company is planning to evaluate the full data outputs.
    • 12 Mar 2018 According to an Anthera Pharmaceuticals media release, based on he data from this trial the company is discontinuing further clinical development of Sollpura including the 20-Week Extension Period of RESULT, the SIMPLICITY study and the EASY study.
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