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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
oral, enterically-coated, pig-derived, pancreatic enzyme replacement
Coefficient of Fat Absorption (CFA)
Non-inferiority of Liprotamase to approved porcine PERT
Time frame: 8 weeks
Coefficient of Nitrogen Absorption (CNA)
Non-inferiority of Liprotamase to approved porcine PERT
Time frame: 8 weeks
Safety, as measured by number of participants with adverse events or laboratory abnormalities
Change from baseline
Time frame: 6 months
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