RESULT: Reliable, Emergent Solution Using Liprotamase Treatment

Status unconfirmed · Phase 3

Conditions studied: Exocrine Pancreatic Insufficiency, Cystic Fibrosis

In brief

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).

Key facts

Study ID

NCT03051490

Run by

Anthera Pharmaceuticals

People needed

140

Starts

2017-04-28

Expected to finish

2018-06-01

Last updated by the study team

2018-03-08

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
• Good disease control with porcine PERT prior to enrollment
• 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 139 — Little Rock, Arkansas, United States
• Investigator Site #123 — Long Beach, California, United States
• Investigator Site 107 — Los Angeles, California, United States
• Investigator Site 143 — Orange, California, United States
• Investigator Site 150 — Denver, Colorado, United States
• Investigator Site 147 — Wilmington, Delaware, United States
• Investigator Site 117 — Altamonte Springs, Florida, United States
• Investigator Site 102 — Jacksonville, Florida, United States
• Investigator Site 130 — Miami, Florida, United States
• Investigator Site 151 — West Palm Beach, Florida, United States
• Investigator Site 110 — Atlanta, Georgia, United States
• Investigator Site 109 — Glenview, Illinois, United States
• Investigator Site 148 — Iowa City, Iowa, 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 140 — Kalamazoo, Michigan, United States
• Investigator Site 134 — Jackson, Mississippi, United States
• Investigator Site 135 — Las Vegas, Nevada, United States
• Investigator Site 118 — Durham, North Carolina, United States
• Investigator Site #103 — Cleveland, Ohio, United States
• Site Investigator #113 — Toledo, Ohio, 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.