SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis
Status:
Completed
Trial end date:
2017-01-20
Target enrollment:
Participant gender:
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.