A nine-month, open-label randomized, active controlled phase III study of ALN-AT3 in subjects with severe haemophilia A or B with inhibitors.

Trial Profile

A nine-month, open-label randomized, active controlled phase III study of ALN-AT3 in subjects with severe haemophilia A or B with inhibitors.

Suspended
Phase of Trial: Phase III

Latest Information Update: 07 Sep 2017

At a glance

  • Drugs Fitusiran (Primary)
  • Indications Haemophilia A; Haemophilia B
  • Focus Registrational; Therapeutic Use
  • Acronyms ATLAS-INH
  • 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 a phase 2 open label extension study (258054), 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top