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Prospective, Randomised, Controlled Phase 2 Study Investigating the Haemostatic Efficacy and Safety of Fibrinogen Concentrate (Octafibrin) and Cryoprecipitate as Fibrinogen Supplementation Sources in Patients Undergoing Cytoreductive Surgery for Pseudomyxoma Peritonei

Trial Profile

Prospective, Randomised, Controlled Phase 2 Study Investigating the Haemostatic Efficacy and Safety of Fibrinogen Concentrate (Octafibrin) and Cryoprecipitate as Fibrinogen Supplementation Sources in Patients Undergoing Cytoreductive Surgery for Pseudomyxoma Peritonei

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 05 Nov 2019

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At a glance

  • Drugs Fibrinogen (Primary) ; Fibrinogen
  • Indications Surgical blood loss
  • Focus Registrational; Therapeutic Use
  • Acronyms FORMA-05
  • Sponsors Octapharma
  • Most Recent Events

    • 05 Nov 2019 According to an Octapharma media release, the human fibrinogen concentrate fibryga has received approval for use in treatment of acquired fibrinogen deficiency (AFD) in 15 European countries. The approval extends the market authorisation for fibryga, which is already approved for use in patients with congenital fibrinogen deficiency.The approval of fibryga for use in AFD is based on results of this clinical (FORMA-05) study.
    • 05 Nov 2019 According to Octapharma media release, results from this trial were discussed at American Society of Anesthesiologists Annual Meeting
    • 26 Oct 2019 Results comparing the haemostatic efficacy and safety of human fibronogen concentrate published in the Journal of Thrombosis and Haemostasis
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