NCT02734810

SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis

A Phase 3, Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Anthera Pharmaceuticals · Industry
• Sex: All
• Age: 28 Days
• Healthy volunteers: Not accepted

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).

Conditions

• Exocrine Pancreatic Insufficiency
• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Liprotamase Powder for Oral Solution	Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-12-01
• Completion: 2017-03-01
• First posted: 2016-04-12
• Last updated: 2018-05-11
• Results posted: 2018-05-11

Locations

21 sites across 1 country: United States