SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis

Completed · Phase 3

Conditions studied: Exocrine Pancreatic Insufficiency, Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT02279498

Run by

Anthera Pharmaceuticals

People needed

128

Starts

2015-06-01

Expected to finish

2017-01-20

Last updated by the study team

2018-08-14

Who can join

Age: 7 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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%

Where it is running

• Investigator Site 107 — Los Angeles, California, United States
• Investigator Site 114 — Aurora, Colorado, United States
• Investigator Site 120 — Gainesville, Florida, United States
• Investigator Site 102 — Jacksonville, Florida, United States
• Investigator Site 130 — Miami, Florida, United States
• Investigator Site 117 — Orlando, Florida, United States
• Investigator Site 110 — Atlanta, Georgia, United States
• Investigator Site 127 — Chicago, Illinois, United States
• Investigator Site 109 — Glenview, Illinois, United States
• Investigator Site 104 — Indianapolis, Indiana, United States
• Investigator Site 105 — Wichita, Kansas, United States
• Investigator Site 128 — Lexington, Kentucky, United States
• Investigator Site 122 — Louisville, Kentucky, United States
• Investigator Site 132 — Portland, Maine, United States
• Investigator Site 124 — Ann Arbor, Michigan, United States
• Investigator Site 126 — East Lansing, Michigan, United States
• Investigator Site 134 — Jackson, Mississippi, United States
• Investigator Site 135 — Las Vegas, Nevada, United States
• Investigator Site 103 — Cleveland, Ohio, United States
• Investigator Site 113 — Toledo, Ohio, United States
• Investigator Site 101 — Oklahoma City, Oklahoma, United States
• Investigator Site 136 — Oklahoma City, Oklahoma, United States
• Investigator Site 119 — Portland, Oregon, United States
• Investigator Site 106 — Hershey, Pennsylvania, United States
• Investigator Site 123 — Long Beach, California, United States

Full record on ClinicalTrials.gov

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