NCT02279498.

Trial name or title	A Phase 3, Randomized, Open‐Label, Assessor‐Blind, Noninferiority, Active‐Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis‐Related Exocrine Pancreatic Insufficiency
Methods	Randomized, parallel, open label. Multicentre (54 locations) in USA and Europe.
Participants	Estimated enrolment 126 participants aged at least 7 years, males and females.
Interventions	Liprotamase (oral, soluble, non‐enterically coated, non‐porcine PERT) versus porcine PERT (oral, enterically‐coated PERT prepared from a porcine source).
Outcomes	CFA (change from baseline CFA after up to 8 weeks of stabilized therapy). Safety (number of participants with adverse events or laboratory abnormalities at 18‐20 weeks).
Starting date	June 2015
Contact information	Anthera Pharmaceuticals
Notes	Expected completion: May 2017.

CFA: coefficient of fat absorption
 PERT: pancreatic enzyme replacement therapy