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

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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 24 Nov 2017

At a glance

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

    • 04 May 2016 Status changed from not yet recruiting to recruiting.
    • 14 Oct 2015 Planned initiation date changed from 1 Aug 2015 to 1 Dec 2015, as reported by ClinicalTrials.gov.
    • 08 Apr 2015 New trial record
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