At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Liprotamase and porcine (pig) PERT for Exocrine Pancreatic Insufficiency and Cystic Fibrosis. Completed, enrolled 128 participants across 54 sites in 7 countries.
Detailed Summary
Liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes including lipase, protease, and amylase. The purpose of the present study is to provide additional efficacy and safety data compared to approved, porcine-derived, enterically-coated and encapsulated pancreatic enzyme replacement therapy. The primary efficacy endpoint of the study will be comparative efficacy measured as the change in the coefficient of fat absorption (CFA) in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI). Liprotamase is stable in stomach and digestive fluids allowing administration in a variety of convenient formulations and with a number of foods without enteric coating.
Study Details
Timeline
Interventions
oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
oral, enterically-coated, pancreatic replacement enzymes prepared from a porcine source