RESULT: Reliable, Emergent Solution Using Liprotamase Treatment

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anthera Pharmaceuticals

Criteria

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%