Prospective clinical study in children with severe haemophilia A to investigate clinical efficacy, immunogenicity, pharmacokinetics, and safety of Human-cl rhFVIII

Trial Profile

Prospective clinical study in children with severe haemophilia A to investigate clinical efficacy, immunogenicity, pharmacokinetics, and safety of Human-cl rhFVIII

Completed
Phase of Trial: Phase I/II

Latest Information Update: 31 Jul 2015

At a glance

  • Drugs Simoctocog alfa (Primary)
  • Indications Haemophilia A
  • Focus Registrational; Therapeutic Use
  • Sponsors Octapharma
  • Most Recent Events

    • 06 Aug 2014 The European Commission has approved simoctocog alfa for the treatment and prophylaxis of bleeding in patients with haemophilia A based on the results of GENA-01, GENA-03 and GENA-08, according to an Octapharma media release.
    • 01 Apr 2014 New trial record
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