Trial Profile

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

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.
21 Jan 2020 Results presented in an Octapharma media release.

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