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HELIOS-B: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)

Trial Profile

HELIOS-B: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 25 Mar 2024

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At a glance

  • Drugs Vutrisiran (Primary) ; Pregnancy-multivitamin
  • Indications Transthyretin-related hereditary amyloidosis
  • Focus Adverse reactions; Registrational
  • Acronyms HELIOS-B
  • Sponsors Alnylam Pharmaceuticals
  • Most Recent Events

    • 15 Feb 2024 According to an Alnylam Pharmaceuticals media release, topline results are expected to be available in late June or early July.
    • 15 Feb 2024 According to an Alnylam Pharmaceuticals media release, the company announces updates to the statistical analysis plan that will include updates to the primary and secondary endpoint structure, as well as study exposure.
    • 13 Dec 2023 According to an Alnylam Pharmaceuticals media release, the company plan to submit a Supplemental New Drug Application (sNDA) for the cardiomyopathy of ATTR amyloidosis in mid-2024, assuming positive HELIOS-B results.
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