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A Prospective, Controlled, Randomised, Cross-over Study Investigating the Pharmacokinetic Properties, Surrogate Efficacy and Safety of Octafibrin Compared to Haemocomplettan.Riastap in Subjects With Congenital Fibrinogen Deficiency

Trial Profile

A Prospective, Controlled, Randomised, Cross-over Study Investigating the Pharmacokinetic Properties, Surrogate Efficacy and Safety of Octafibrin Compared to Haemocomplettan.Riastap in Subjects With Congenital Fibrinogen Deficiency

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 03 Jul 2019

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At a glance

  • Drugs Fibrinogen (Primary)
  • Indications Afibrinogenaemia
  • Focus Pharmacokinetics; Therapeutic Use
  • Sponsors Octapharma
  • Most Recent Events

    • 04 Dec 2018 Results assessing the efficacy and PK of Fibryga in Treating Acute Bleeding in Adolescent Patients with Congenital Fibrinogen Deficiency using data from FORMA-01 and FORMA-02 studies, presented at the 60th Annual Meeting and Exposition of the American Society of Hematology
    • 08 Dec 2017 Primary endpoint of fibrinogen activity normalized area under the curve standardized (AUCnorm) has not been met according to results published in the Journal of Thrombosis and Haemostasis.
    • 08 Dec 2017 Primary endpoint of maximum clot firmness at 1 hr Post Infusion has not been met, according to results published in the Journal of Thrombosis and Haemostasis.
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