NCT02823964

EASY: Extended Access to Sollpura Over Years

An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Anthera Pharmaceuticals · Industry
• Sex: All
• Age: 7 Years
• 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.

Detailed description

The purpose of the present study is to evaluate the safety of long-term use of liprotamase in the management of cystic fibrosis-related exocrine pancreatic insufficiency

Conditions

• Exocrine Pancreatic Insufficiency
• Cystic Fibrosis

Interventions

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

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2016-07-06
• Last updated: 2018-05-17
• Results posted: 2018-05-17

Locations

15 sites across 6 countries: United States, Czechia, Hungary, Israel, Poland, Spain