Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of Human-cl rhFVIII, a Newly Developed Human Cell-line Derived Recombinant FVIII Concentrate in Previously Treated Patients With Severe Hemophilia A

Trial Profile

Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of Human-cl rhFVIII, a Newly Developed Human Cell-line Derived Recombinant FVIII Concentrate in Previously Treated Patients With Severe Hemophilia A

Completed
Phase of Trial: Phase II

Latest Information Update: 10 Nov 2014

At a glance

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

    • 10 Nov 2014 According to an Octapharma Canada media release, Health Canada approved Nuwiq (simoctocog alfa) for the treatment and prophylaxis of bleeding in all age groups with haemophilia A (congenital factor VIII deficiency), based on the results of this trial and two other trials (GENA-03 and GENA-08; see CT profiles 700242643 and 700242641).
    • 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.
    • 27 Mar 2014 New trial record
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