Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

RESULT: Reliable, Emergent Solution Using Liprotamase Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03051490
Recruitment Status : Unknown
Verified January 2018 by Anthera Pharmaceuticals.
Recruitment status was:  Active, not recruiting
First Posted : February 13, 2017
Last Update Posted : March 8, 2018
Information provided by (Responsible Party):
Anthera Pharmaceuticals

Brief 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).

Condition or disease Intervention/treatment Phase
Exocrine Pancreatic Insufficiency Cystic Fibrosis Drug: Liprotamase Drug: porcine PERT Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: unblinded to treatment randomization; blinded to primary efficacy variable
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
Actual Study Start Date : April 28, 2017
Actual Primary Completion Date : February 28, 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: Liprotamase
Individually-optimized dose to be administered orally
Drug: Liprotamase
oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement

Active Comparator: porcine PERT
Individually-optimized dose to be administered orally
Drug: porcine PERT
oral, enterically-coated, pig-derived, pancreatic enzyme replacement

Primary Outcome Measures :
  1. Coefficient of Fat Absorption (CFA) [ Time Frame: 8 weeks ]
    Non-inferiority of Liprotamase to approved porcine PERT

Secondary Outcome Measures :
  1. Coefficient of Nitrogen Absorption (CNA) [ Time Frame: 8 weeks ]
    Non-inferiority of Liprotamase to approved porcine PERT

  2. Safety, as measured by number of participants with adverse events or laboratory abnormalities [ Time Frame: 6 months ]
    Change from baseline

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03051490

Show Show 50 study locations
Sponsors and Collaborators
Anthera Pharmaceuticals
Layout table for investigator information
Study Director: Monica Gangal Anthera Pharmaceuticals
Layout table for additonal information
Responsible Party: Anthera Pharmaceuticals Identifier: NCT03051490    
Other Study ID Numbers: AN-EPI3333
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: January 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases