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

Trial Profile

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

Discontinued
Phase of Trial: Phase II

Latest Information Update: 11 Jun 2018

At a glance

  • Drugs Birtamimab (Primary)
  • Indications Amyloid light-chain amyloidosis
  • Focus Adverse reactions
  • Acronyms OLE
  • 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 active, no longer recruiting to discontinued, according to a Prothena media release.
    • 23 Oct 2017 Planned End Date changed from 1 Dec 2017 to 1 Dec 2019.
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