RESULT: Reliable, Emergent Solution Using Liprotamase Treatment
Status:
Unknown status
Trial end date:
2018-06-01
Target enrollment:
Participant gender:
Summary
Liprotamase powder is a non-porcine, soluble and stable mixture of biotechnology-derived
lipase, protease, and amylase digestive enzymes. The purpose of the present study is to to
evaluate the non-inferiority of liprotamase compared with porcine-derived, enterically-coated
pancreatic enzyme replacement therapy (PERT). The primary efficacy endpoint of the study will
be comparative efficacy measured as the change from baseline in the coefficient of fat
absorption (CFA) in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).