ATLAS-INH: A Phase 3 study to evaluate the efficacy and safety of fitusiran in patients with hemophilia A or B, with inhibitory antibodies to factor VIII or IX

Trial Profile

ATLAS-INH: A Phase 3 study to evaluate the efficacy and safety of fitusiran in patients with hemophilia A or B, with inhibitory antibodies to factor VIII or IX

Recruiting
Phase of Trial: Phase III

Latest Information Update: 15 Apr 2018

At a glance

  • Drugs Fitusiran (Primary)
  • Indications Haemophilia A; Haemophilia B
  • Focus Registrational; Therapeutic Use
  • Acronyms ATLAS-INH
  • Sponsors Alnylam Pharmaceuticals
  • Most Recent Events

    • 15 Dec 2017 According to a Sanofi media release, based on the protocol amendments and other updated clinical materials for Fitusiran, U.S. Food and Drug Administration (FDA) has lifted the hold on all clinical studies with Fitusiran.
    • 15 Dec 2017 Status changed from suspended to recruiting, according to a Sanofi media release.
    • 09 Nov 2017 According to an Alnylam Pharmaceuticals media release, alignment reached with FDA on amended safety measures and risk mitigation strategy to enable resumption of fitusiran clinical program. Reinitiation of dosing will be announced around year end.
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