At a glance
ClinicalIndex Comparison Record- ✓Age ≥7 years (Part A) or 28 days to <7 years (Part B)
- ✓Confirmed diagnosis of cystic fibrosis based on clinical presentation, genotype, and/or sweat chloride test
- ✓Low fecal elastase
- ✓Fair-to-good nutritional status
- ✕History or current diagnosis of fibrosing colonopathy
- ✕Distal intestinal obstruction syndrome (DIOS) within 6 months prior to screening
- ✕Currently receiving enteral tube feedings
- ✕Chronic diarrheal illness unrelated to pancreatic insufficiency
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
In Brief
A Phase 3 clinical trial evaluating Liprotamase Powder for Oral Solution for Exocrine Pancreatic Insufficiency and Cystic Fibrosis. Completed, enrolled 15 participants across 21 sites.
Detailed 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).
Study Details
Timeline
Interventions
Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy