• Research type

    Research Study

  • Full title

    Nuwiq Dosing and outcomes In the ManagEment of women/girls with haemophilia A Needing FVIII treatment for Surgery – an International, Open-label, Non-controlled study (NuDIMENSION)



  • Contact name

    Sigurd Knaub

  • Contact email

  • Sponsor organisation

    Octapharma AG

  • Eudract number


  • Identifier


  • Research summary

    This is a phase 4, prospective, open-label, uncontrolled, single-arm, multinational, multicentre study that will be conducted at
    approximately 15 sites worldwide. All patients are scheduled to undergo a major surgical procedure and will perioperative be receiving Nuwiq. A maximum of 28 patients will be enrolled in order to document 26 evaluable major surgeries (each subject can have only one surgery in the study). Each patient (women/girls only) will be in the study from the time of the screening visit until 30 days after the day of the surgical procedure or at the day of discharge (whichever comes last). The primary objective of this study is to evaluate the overall perioperative haemostatic efficacy of Nuwiq in women/girls with haemophilia A undergoing major surgery.

  • REC name

    South Central - Hampshire A Research Ethics Committee

  • REC reference


  • Date of REC Opinion

    2 Feb 2024

  • REC opinion

    Further Information Favourable Opinion