rFVIII in Prevention & On-Demand Treatment of Bleeds in Haemophilia A

• Research type

  Research Study

• Full title

  Safety and Efficacy of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Subjects with Haemophilia A Sub-Trial: Efficacy and Safety of N8 in Prevention and Treatment of Bleeding during Surgical Procedures in Subjects with Haemophilia A

• IRAS ID

  54936

• Contact name

  Charles Hay

• Sponsor organisation

  Novo Nordisk Ltd

• Eudract number

  2008-005945-46

• Research summary

  The NN7008-3568 trial is a prospective clinical phase 3b trial intended at demonstrating long-term safety and efficacy of N8 in previously treated patients with severe haemophilia A previously exposed to N8 as part of the NN7008-3543 trial. The study consists of the main part and a sub-trial for patients who need to undergo surgery. Main Part: This study will run until market authorisation of N8 in the UK. There are 19 visits although this can be changed depending on when market authorisation is granted. The first visit will be the end of trial visit for the NN7008-3543 trial. The patients will receive N8 for either a preventative regimen or an on-demand regimen, which will be decided by the investigator. A patient on a preventative regimen will receive either 20-50 IU/kg body weight once every second day or 20-60 IU/kg BW three times weekly with on-demand treatment for breakthrough bleeds. A patient on on-demand treatment will receive N8 as bleeds occur and occasionally as preventative treatment (for example prior to physical activity). The patients can continue on the same dose as in the NN7008-3543 trial. All home treatments will be self-injection iv by the subject or a support person. A diary will be used to record information about bleeds including a self-assessment of the haemostatic response. All subjects have the possibility to undergo major and minor surgery as part of the Sub-Trial if the surgical intervention requires at least 7 days of N8 surgery related treatment including the day of surgery. Bolus and continuous infusion with N8 can be used during surgery. However, continuous infusion can only be used if subjects are scheduled for major elective surgery. Surgical procedures that require less than 7 days of surgery related treatment with N8 (i.e. uncomplicated minor surgical procedures) are not included in the Sub-Trial, but defined as Other Surgical Procedures.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  10/H1002/56

• Date of REC Opinion

  16 Nov 2010

• REC opinion

  Further Information Favourable Opinion