Cystic Fibrosis Clinical Trial
Official 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
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.
Porcine derived enzymes are used for pancreatic enzyme replacement therapy in patients with cystic fibrosis (CF). Liprotamase is a biotechnology-derived enzyme replacement without enteric coating. This is an open-label, assessor blind, parallel group, multicenter, international trial to evaluate the noninferiority of liprotamase and pancrelipase in CF patients aged ≥7 years with pancreatic insufficiency. Subjects were randomized to liprotamase or pancrelipase, dose-matched to pre-study lipase doses. The lower bound of the 95% confidence interval (CI) for noninferiority was -15% for treatment difference in change from baseline coefficient of fat absorption (CFA). ;
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