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RESULT: Reliable, Emergent Solution Using Liprotamase Treatment

NCT03051490 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2018-03-08

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

Liprotamase

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

DRUG

porcine PERT

oral, enterically-coated, pig-derived, pancreatic enzyme replacement

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
2017-04-28
Primary Completion
2018-02-28
Completion
2018-06-30
FDA Drug
Yes

Countries

  • United States
  • Hungary
  • Israel
  • Lithuania
  • Poland
  • Spain
  • United Kingdom

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 NCT03051490 on ClinicalTrials.gov