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Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of NEOD001 in Subjects With Light Chain (AL) Amyloidosis

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Trial Profile

Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of NEOD001 in Subjects With Light Chain (AL) Amyloidosis

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 19 Jan 2024

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At a glance

  • Drugs Birtamimab (Primary)
  • Indications Amyloid light-chain amyloidosis
  • Focus Adverse reactions
  • Acronyms OLE
  • Sponsors Prothena

    • Most Recent Events

    • 12 Dec 2023 Results of pooled analysis of phase 1-3 studies ((NCT01707264) with open-label extension (OLE; NCT02613182) and 2 RCTs (Phase 2 PRONTO with OLE [NCT03154047] and Phase 3 VITAL)) assessing safety from birtamimab, presented at the 65th American Society of Hematology Annual Meeting and Exposition.
    • 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 active, no longer recruiting to discontinued, according to a Prothena media release.

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