RESULT: Reliable, Emergent Solution Using Liprotamase Treatment
Status and phase
Conditions
Treatments
Details and patient eligibility
About
Liprotamase powder is a non-porcine, soluble and stable mixture of biotechnology-derived lipase, protease, and amylase digestive enzymes. The purpose of the present study is to to evaluate the non-inferiority of liprotamase compared with porcine-derived, enterically-coated pancreatic enzyme replacement therapy (PERT). The primary efficacy endpoint of the study will be comparative efficacy measured as the change from baseline in the coefficient of fat absorption (CFA) in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Diagnosis of Cystic Fibrosis based on presentation, genotype and/or sweat chloride
- Fecal elastase <100 mcg/g stool
- Good disease control with porcine PERT prior to enrollment
- 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%
Trial design
Primary purpose
Allocation
Interventional model
Masking
140 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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