SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anthera Pharmaceuticals
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• For Part A: males or females ≥7 years of age

• For Part B: males or females 28 days to <7 years

• Diagnosis of cystic fibrosis based on presentation, genotype and/or sweat chloride

• Low fecal elastase

• Fair-to-good nutritional status

Exclusion Criteria:

• History or diagnosis of fibrosing colonopathy

• Distal intestinal obstruction syndrome in 6 months prior to screening

• Receiving enteral tube feedings

• Chronic diarrheal illness unrelated to pancreatic insufficiency

• Liver abnormalities, or liver or lung transplant, or significant bowel resection