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
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History