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).
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
20
sites
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