RESULT: Reliable, Emergent Solution Using Liprotamase Treatment
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 7 - Any |
| Updated: | 4/17/2018 |
| Start Date: | April 28, 2017 |
| End Date: | June 2018 |
A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
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).
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).
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%
We found this trial at
28
sites
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