NN7008-3543 Prevention and Treatment of Bleeds in Haemophilia A

  • Research type

    Research Study

  • Full title

    A Multi-Centre, Open-Label, Non-Controlled Trial on Efficacy and Safety of N8 in Prevention and Treatment of Bleeds in Previously Treated Subjects with Haemophilia A. Sub Trial: Safety and Efficacy of N8 in Prevention and Treatment of Bleeding during Surgical Procedures in Subjects with Haemophilia A

  • IRAS ID

    26498

  • Contact name

    Charles Hay

  • Sponsor organisation

    Novo Nordisk Ltd

  • Eudract number

    2008-003960-20

  • Research summary

    The trial design will provide information on the bleeding-preventive and bleeding-arresting haemostatic response and safety profile of N8 in previously treated patients with severe haemophilia A without inhibitors. The study consists of 3 parts; A, B & C. The aim of Part A was to evaluate the efficacy of N8 in bleeding prevention and on demand treatment and the PK profile of N8. This part of the trial has already been completed. The UK did not take part in Part A of the Study. The UK is participating in parts B and C. Part B: Subjects will receive bleeding preventive treatment with N8 in a dose of 20-40 IU/kg BW every second day or 20-50 IU/kg BW three times per week. This is a standard dose for Haemophilia Prophylaxis. The bleeding preventative treatment will be home treatment with self-injection i.v. by the subject or a support person every second day or three times per week. A diary will be used to record information about bleeds. Such bleeds must be reported to the site and entered in the diary by the subject with a self assessment of the haemostatic response. Subjects will have to attend 10 hospital visits over a 6-8 month period. Subjects who need to undergo surgery during the trial will be asked to take part in a sub study (part C). This sub study design will provide information on the bleeding-preventive effect during surgery, the bleeding-arresting haemostatic response during these procedures and the safety profile of N8 in patients with haemophilia A without inhibitors. The sub study will cover from the day of surgery until the patient returns to preventative treatment in the main study.

  • REC name

    North West - Liverpool Central Research Ethics Committee

  • REC reference

    10/H1002/16

  • Date of REC Opinion

    23 Mar 2010

  • REC opinion

    Favourable Opinion