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A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects With Light Chain (AL) Amyloidosis Who Were Previously Enrolled in Study NEOD001-201 (PRONTO)

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Trial Profile

A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects With Light Chain (AL) Amyloidosis Who Were Previously Enrolled in Study NEOD001-201 (PRONTO)

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 05 Nov 2021

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At a glance

  • Drugs Birtamimab (Primary)
  • Indications Amyloid light-chain amyloidosis
  • Focus Adverse reactions
  • Acronyms PRONTO
  • Sponsors Prothena
  • Most Recent Events

    • 23 Apr 2018 According to a Prothena media release, based on the results of PRONTO study, the independent data monitoring committee reviewed a futility analysis of the VITAL study and recommended a discontinuation of the VITAL study as well as the open label extension studies for futility.
    • 23 Apr 2018 Status changed from recruiting to discontinued, according to a Prothena media release.
    • 23 Jun 2017 Status changed from not yet recruiting to recruiting.

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