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An Open-label, Long-term Safety and Efficacy Study of Fitusiran in Patients With Hemophilia A or B, With or Without Inhibitory Antibodies to Factor VIII or IX

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Trial Profile

An Open-label, Long-term Safety and Efficacy Study of Fitusiran in Patients With Hemophilia A or B, With or Without Inhibitory Antibodies to Factor VIII or IX

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Oct 2026

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At a glance

  • Drugs Fitusiran (Primary)
  • Indications Haemophilia A; Haemophilia B
  • Focus Adverse reactions; Registrational
  • Acronyms ATLAS-OLE
  • Sponsors Sanofi Genzyme

Most Recent Events

  • 30 Sep 2026 Status changed from active, no longer recruiting to completed.
  • 28 Mar 2025 According to Sanofi Media Release, the US FDA approved Qfitlia (fitusiran), as the first therapy in the US to treat hemophilia A or B with or without inhibitors based on the data from this trail along with other ATLAS trials.
  • 21 Jun 2024 According to Sanofi Media Release, the regulatory submissions for fitusiran for the treatment of hemophilia A or B in adults and adolescents with or without inhibitors have been completed in China, Brazil and the US with a US Food and Drug Administration (FDA) target action date of March 28, 2025.

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