NN1731-3562: Efficacy & Safety of NNC 0078-0000-0007

• Research type

  Research Study

• Full title

  Efficacy and Safety of NNC 0078-0000-0007 in Treatment of Acute Bleeding Episodes in Patients with Congenital Haemophilia and Inhibitors.

• IRAS ID

  74815

• Sponsor organisation

  Novo Nordisk A/S

• Eudract number

  2010-023803-92

• ISRCTN Number

  na

• Research summary

  The purpose of this phase 3 trial is to confirm the efficacy and safety of NNC 0078-0000-0007 in haemophilia patients with inhibitors (antibodies that develop and prevent factor concentrates from working). NNC 0078-0000-0007, also referred to as Vatreptacog alfa, is a recombinant (produced in a laboratory and free of animal based serum) FVIIa molecule which in phase 1 and 2 trials have shown a fast acting profile suitable for treatment of bleeding episodes in patients with haemophilia and inhibitors.This is a global multi-centre, randomised, double-blind, active controlled confirmatory phase 3 trial designed to demonstrate the efficacy and safety of Vatreptacog alfa for treatment of acute bleeds in patients with congenital (inherited) haemophilia with inhibitors. A treatment regimen with rFVIIa will be included as an active control.Each bleeding episode will be treated by a random sequence of two different regimens:1-3 doses of Vatreptacog alfa at 80u(micro)g/kg bw and1-3 doses of rFVIIa at 90ug/kg bw (corresponding to the active drug in NovoSeven).The trial has an expected duration of 21 months,

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  11/SC/0170

• Date of REC Opinion

  1 Jun 2011

• REC opinion

  Further Information Favourable Opinion