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: 20 Aug 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

    • 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.
    • 09 Aug 2017 According to an Anthera Pharmaceuticals media release, screening of patients in the U.S. and Europe has been initiated. study began enrollment in the U.S. in May and in Europe in July.
    • 10 Jul 2017 According to an Anthera Pharmaceuticals media releas, the Cystic Fibrosis Foundation Therapeutics Development Network (CFF TDN) Protocol Review Committee has approved the protocol for this (RESULT) study, which may result in additional TDN investigational sites participating in the study which could further accelerate patient recruitment in the U.S.
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