Phase 3
N=15
SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis
Exocrine Pancreatic Insufficiency · Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT02734810 ↗Enrolled (actual)
15
Serious AEs
6.7%
Results posted
May 2018
Primary outcome: Primary: Safety — 3; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Liprotamase Powder for Oral Solution (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Anthera Pharmaceuticals
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety |
3; 0 | — |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02734810). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.