A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis

Trial Profile

A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis

Completed
Phase of Trial: Phase III

Latest Information Update: 30 May 2016

At a glance

  • Drugs Fibrinogen/thrombin (Primary) ; Gelatin
  • Indications Surgical blood loss
  • Focus Registrational; Therapeutic Use
  • Acronyms FINISH-3
  • Sponsors ProFibrix
  • Most Recent Events

    • 30 Apr 2015 Based on the results of this trial, the US FDA has approved Raplixa (fibrin sealant) and the RaplixaSpray device to provide adjunctive haemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques is ineffective or impractical, according to a media release from The Medicines Company.
    • 30 Mar 2015 According to a media release from The Medicines Company, the EC has granted marketing authorization for fibrinogen/thrombin [Raplixa], followed by positive opinion by the CHMP of the EMA.
    • 28 Oct 2014 Results published in a media release from The Medicines Company.
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