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RESULT: Reliable, Emergent Solution Using Liprotamase Treatment

Anthera Pharmaceuticals logo

Anthera Pharmaceuticals

Status and phase

Unknown
Phase 3

Conditions

Cystic Fibrosis
Exocrine Pancreatic Insufficiency

Treatments

Drug: porcine PERT
Drug: Liprotamase

Study type

Interventional

Funder types

Industry

Identifiers

NCT03051490
AN-EPI3333

Details and patient eligibility

About

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).

Enrollment

140 estimated patients

Sex

All

Ages

7+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

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%

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

140 participants in 2 patient groups

Liprotamase
Experimental group
Description:
Individually-optimized dose to be administered orally
Treatment:
Drug: Liprotamase
porcine PERT
Active Comparator group
Description:
Individually-optimized dose to be administered orally
Treatment:
Drug: porcine PERT

Trial contacts and locations

50

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Data sourced from clinicaltrials.gov

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