Phase 3
Completed N=128
SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis
Source: ClinicalTrials.gov NCT02279498 ↗Enrolled (actual)
128
Serious AEs
10.2%
Results posted
Aug 2018
Primary outcomePrimary: Treatment Difference in Coefficient of Fat Absorption (CFA) Change From Baseline — -11.852 percent change from baseline
◆ Published Evidence
Established
43citations · ~7 / year
Pancreatic enzyme replacement therapy for people with cystic fibrosis.
Summary
Liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes including lipase, protease, and amylase. The purpose of the present study is to provide additional efficacy and safety data compared to approved, porcine-derived, enterically-coated and encapsulated pancreatic enzyme replacement therapy. The primary efficacy endpoint of the study will be comparative efficacy measured as the change in the coefficient of fat absorption (CFA) in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).
Liprotamase is stable in stomach and digestive fluids allowing administration in a variety of convenient formulations and with a number of foods without enteric coating.
Linked Publications
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Pancreatic enzyme replacement therapy for people with cystic fibrosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Difference in Coefficient of Fat Absorption (CFA) Change From Baseline |
-11.852 | — |
| SECONDARY Coefficient of Fat Absorption (CFA) |
76.5; 89.5 | — |
| SECONDARY Coefficient of Nitrogen Absorption (CNA) |
95.8; 97.5 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Cystic Fibrosis based on presentation, genotype and/or sweat chloride
- Fecal elastase <100 mcg/g stool
- Minimum Coefficient of Fat (CFA) at screening while on stable PERT therapy
- 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
- Forced expiratory volume in 1 second (FEV1) <30%
Data sourced from ClinicalTrials.gov (NCT02279498) and the linked publication. 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. Informational only — not medical advice.