A Phase 3 interventional study of Liprotamase and porcine PERT in Exocrine Pancreatic Insufficiency and Cystic Fibrosis, sponsored by Anthera Pharmaceuticals. Status unknown at 50 sites in 7 countries. Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2018-03-08.
Sponsored by Anthera Pharmaceuticals · Phase 3, Interventional, and Treatment
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).
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's planned enrollment of 140 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Anthera Pharmaceuticals is the lead sponsor of 25 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Individually-optimized dose to be administered orally
Drug: Liprotamase
Individually-optimized dose to be administered orally
Drug: porcine PERT
oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
oral, enterically-coated, pig-derived, pancreatic enzyme replacement
Coefficient of Fat Absorption (CFA)
Non-inferiority of Liprotamase to approved porcine PERT
Time frame: 8 weeks
Coefficient of Nitrogen Absorption (CNA)
Non-inferiority of Liprotamase to approved porcine PERT
Time frame: 8 weeks
Safety, as measured by number of participants with adverse events or laboratory abnormalities
Change from baseline
Time frame: 6 months
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Anthera Pharmaceuticals