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Prospective, Open-label, Uncontrolled, Phase III Study to Assess the Efficacy, Safety and Pharmacokinetic of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery in Paediatric Subjects With Congenital Fibrinogen Deficiency

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Trial Profile

Prospective, Open-label, Uncontrolled, Phase III Study to Assess the Efficacy, Safety and Pharmacokinetic of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery in Paediatric Subjects With Congenital Fibrinogen Deficiency

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Fibrinogen (Primary)
  • Indications Afibrinogenaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms FORMA04
  • Sponsors Octapharma

    • Most Recent Events

    • 29 Mar 2021 According to a Food and Drug Administration media release, for fibryga (human fibrinogen concentrate), the FDA approved Octapharmas request to expand the indication for on-demand treatment of acute bleeding episodes to pediatric patients less than 12 years old with congenital fibrinogen deficiency (CFD), also known as Factor 1 deficiency. The expansion was supported by the results of this Phase 3 study.
    • 29 Mar 2021 According to a Food and Drug Administration media release, results from the FORMA-02 and FORMA-04 clinical trials will be presented at the virtual American Society of Pediatric Hematology/Oncology (ASPHO) 2021.
    • 08 Dec 2020 Results assessing efficacy and safety of HFC for the treatment of bleeding episodes (BEs) and surgical prophylaxis in adult, adolescent and pediatric patients from two studies (FORMA-02 and FORMA-04 ), presented at the 62nd Annual Meeting and Exposition of the American Society of Hematology.
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