Overview

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