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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.
 
ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE February 9, 2017
First Posted Date  ICMJE February 13, 2017
Last Update Posted Date March 8, 2018
Actual Study Start Date  ICMJE April 28, 2017
Actual Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2017)
Coefficient of Fat Absorption (CFA) [ Time Frame: 8 weeks ]
Non-inferiority of Liprotamase to approved porcine PERT
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2017)
  • Coefficient of Nitrogen Absorption (CNA) [ Time Frame: 8 weeks ]
    Non-inferiority of Liprotamase to approved porcine PERT
  • Safety, as measured by number of participants with adverse events or laboratory abnormalities [ Time Frame: 6 months ]
    Change from baseline
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RESULT: Reliable, Emergent Solution Using Liprotamase Treatment
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
unblinded to treatment randomization; blinded to primary efficacy variable
Primary Purpose: Treatment
Condition  ICMJE
  • Exocrine Pancreatic Insufficiency
  • Cystic Fibrosis
Intervention  ICMJE
  • Drug: Liprotamase
    oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
  • Drug: porcine PERT
    oral, enterically-coated, pig-derived, pancreatic enzyme replacement
Study Arms  ICMJE
  • Experimental: Liprotamase
    Individually-optimized dose to be administered orally
    Intervention: Drug: Liprotamase
  • Active Comparator: porcine PERT
    Individually-optimized dose to be administered orally
    Intervention: Drug: porcine PERT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 23, 2018)
140
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2017)
150
Estimated Study Completion Date  ICMJE June 2018
Actual Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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%
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   Israel,   Lithuania,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03051490
Other Study ID Numbers  ICMJE AN-EPI3333
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anthera Pharmaceuticals
Study Sponsor  ICMJE Anthera Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Monica Gangal Anthera Pharmaceuticals
PRS Account Anthera Pharmaceuticals
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP