Conditions: Exocrine Pancreatic Insufficiency Cystic Fibrosis
Keywords: Exocrine Pancreatic Insufficiency Cystic Fibrosis Liprotamase Pancreatic Enzyme Replacement Therapy (PERT)
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 15
Healthy volunteers: no

Brief summary:
Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be formulated without enteric coating for administration either as a capsule or as a dosing solution dissolved in water or juice. The purpose of the present study is to provide efficacy and safety data for a new, soluble formulation of liprotamase, Liprotamase Powder for Oral Solution, in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).

Detailed description:

Arms:
arm 1: Liprotamase Powder for Oral Solution in Subjects aged ≥7 years of age arm 2: Liprotamase Powder for Oral Solution in Subjects aged 28 days to \<7 years

Interventions: intervention 1: Liprotamase Powder for Oral Solution
Intervention descriptions: intervention 1: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy

Protocol document: