An Open-label Extension Study of Subcutaneously Administered ALN-AT3SC in Patients with Moderate or Severe Hemophilia A or B who have Participated in a Previous Clinical Study with ALN-AT3SC

Trial Profile

An Open-label Extension Study of Subcutaneously Administered ALN-AT3SC in Patients with Moderate or Severe Hemophilia A or B who have Participated in a Previous Clinical Study with ALN-AT3SC

Suspended
Phase of Trial: Phase I/II

Latest Information Update: 05 Oct 2017

At a glance

  • Drugs Fitusiran (Primary)
  • Indications Haemophilia A; Haemophilia B
  • Focus Adverse reactions
  • Sponsors Alnylam Pharmaceuticals
  • Most Recent Events

    • 07 Sep 2017 According to an Alnylam Pharmaceuticals media release, based on overall consideration of fitusirans benefit-risk profile, the company expects to resume dosing upon agreement with global regulatory authorities and with appropriate protocol amendments in place for enhanced patient safety monitoring, in all of its clinical studies (Phase 2 OLE and ATLAS Phase 3 program) as soon as possible, potentially as early as late 2017.
    • 07 Sep 2017 Status changed from recruiting to suspended due to a fatal thrombotic event in a patient with hemophilia A who was receiving fitusiran in this study, according to an Alnylam Pharmaceuticals media release.
    • 07 Sep 2017 According to a Sanofi media release, Alnylam has suspended dosing in all ongoing fitusiran studies pending further review of the safety event and development of a risk mitigation strategy.
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