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Nutritional-GI Completed with Results

SIMPLICITY: Phase 3 study of liprotamase in people with CF-related pancreatic insufficiency (Anthera AN-EPI3332)

This study evaluated the safety and effectiveness of a new, water-soluble formulation of liprotamase.

 This two-part study was open-label, meaning that all participants received liprotamase. Part A enrolled participants over 7 years of age for 1 week.  Part B enrolled children aged 28 days to 7 years for 7 weeks followed by an extension period of 17 weeks. 

Eligibility

  • Age:

    28 Days to 17 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    No FEV1 Limit

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Study Results

  • What We Learned:

    Anthera Pharmaceuticals stopped the SIMPLICITY trial before the study completed. This decision was based on negative results from the RESULT study which did not meet its primary endpoint. No further development of liprotamase is planned at this time. 

  • Primary Findings:

    Effectiveness:

    Safety:

  • Citation:

For current information about the overall development status of this drug, please check the Drug Development Pipeline.

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    No

  • Placebo Controlled: ?more info

    No

  • Length of Participation:

    24 weeks

  • Number of Study Visits:

    7

Additional Information

  • Phase: ?more info

    Phase Three

  • Study Sponsor: ?more info

    Anthera

  • Study Drugs:

    Liprotamase

Eligibility

  • Age:

    28 Days to 17 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    No FEV1 Limit

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

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