Phase 3 N=128 Randomized Treatment

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

Exocrine Pancreatic Insufficiency · Cystic Fibrosis

Bottom Line

View on ClinicalTrials.gov: NCT02279498 ↗

Enrolled (actual)

128

Serious AEs

10.2%

Results posted

Aug 2018

Primary outcome: Primary: Treatment Difference in Coefficient of Fat Absorption (CFA) Change From Baseline — -11.852 percent change from baseline

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Liprotamase (Drug); porcine (pig) PERT (Drug)
Age: Pediatric, Adult, Older Adult · 7+ yrs
Sex: All
Sponsor: Anthera Pharmaceuticals
Primary completion: Oct 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Treatment Difference in Coefficient of Fat Absorption (CFA) Change From Baseline	-11.852	—
SECONDARY Coefficient of Fat Absorption (CFA)	76.5; 89.5	—
SECONDARY Coefficient of Nitrogen Absorption (CNA)	95.8; 97.5	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

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

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%

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02279498). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.