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RESULT: Reliable, Emergent Solution Using Liprotamase Treatment

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ClinicalTrials.gov Identifier: NCT03051490
Recruitment Status : Active, not recruiting
First Posted : February 13, 2017
Last Update Posted : March 8, 2018
Sponsor:
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

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



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

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 ClinicalTrials.gov identifier (NCT number): NCT03051490


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Sponsors and Collaborators
Anthera Pharmaceuticals
Investigators
Study Director: Monica Gangal Anthera Pharmaceuticals

Responsible Party: Anthera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03051490     History of Changes
Other Study ID Numbers: AN-EPI3333
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases