SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis

Completed · Phase 3

Conditions studied: Exocrine Pancreatic Insufficiency, Cystic Fibrosis

In brief

Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be formulated without enteric coating for administration either as a capsule or as a dosing solution dissolved in water or juice. The purpose of the present study is to provide efficacy and safety data for a new, soluble formulation of liprotamase, Liprotamase Powder for Oral Solution, in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).

Key facts

Study ID

NCT02734810

Run by

Anthera Pharmaceuticals

People needed

15

Starts

2016-06-01

Expected to finish

2017-03-01

Last updated by the study team

2018-05-11

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For Part A: males or females ≥7 years of age
• For Part B: males or females 28 days to <7 years
• Diagnosis of cystic fibrosis based on presentation, genotype and/or sweat chloride
• Low fecal elastase
• Fair-to-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

Where it is running

• Investigator Site 139 — Little Rock, Arkansas, United States
• Investigator Site — Orange, California, United States
• Investigator Site 114 — Aurora, Colorado, United States
• Investigator Site 117 — Altamonte Springs, Florida, United States
• Investigator Site 138 — Hollywood, Florida, United States
• Investigator Site 130 — Miami, Florida, United States
• Investigator Site 110 — Atlanta, Georgia, United States
• Investigator Site 109 — Glenview, Illinois, United States
• Investigator Site 105 — Wichita, Kansas, 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 135 — Las Vegas, Nevada, United States
• Investigator Site 118 — Durham, North Carolina, United States
• Investigator Site 101 — Oklahoma City, Oklahoma, United States
• Investigator Site 136 — Oklahoma City, Oklahoma, United States
• Investigator Site 106 — Hershey, Pennsylvania, United States
• Investigator Site 111 — Dallas, Texas, United States
• Investigator Site 116 — Houston, Texas, United States
• Investigator Site 112 — Richmond, Virginia, United States
• Investigator Site 129 — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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