SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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).
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
15 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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