MedTrace Logo

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

NCT02279498 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2018-08-14

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Liprotamase

oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement

DRUG

porcine (pig) PERT

oral, enterically-coated, pancreatic replacement enzymes prepared from a porcine source

Sponsors & Collaborators

  • Anthera Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Monica Gangal · Anthera Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-10-31
Completion
2017-01-20

Countries

  • United States
  • Canada
  • Czechia
  • Hungary
  • Israel
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02279498 on ClinicalTrials.gov