SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis

Status:	Completed
Conditions:	Pulmonary
Therapuetic Areas:	Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	Any
Updated:	5/13/2018
Start Date:	June 2016
End Date:	March 2017

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

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).

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

We found this trial at

sites

Clinical Trial Facility in Louisville Kentucky

Louisville, Kentucky 40202

from

Louisville, KY