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    Hemophilia and Rare Bleeding Disorders

    Publication Only

    PO10 - 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)

    Wednesday, June 28, 2023
    13:00 – 14:00 ET
    Room: 10

      Presenting Author(s)

    • Natascha Marquardt, MD

      Senior Physician
      Institute for Experimental Hematology and Transfusion Medicine, University Clinic Bonn
      Bonn, Nordrhein-Westfalen, Germany

      • Co-Author(s)

    • Johannes Oldenburg, MD (he/him/his)

      Professor, Chairman and Director
      University Clinic Bonn AöR, Institute of Experimental Haematology and Transfusion Medicine, Bonn, Germany
      Bonn, Nordrhein-Westfalen, Germany

    • MJ

      Martina Jansen

      Senior Clinical Project Manager
      Octapharma Pharmazeutika Produktionsgesellschaft mbH
      Vienna, Wien, Austria

    • SK

      Sigurd Franz Knaub, PhD

      Senior Vice President Clinical R&D – Haematology
      Octapharma AG
      Lachen, Schwyz, Switzerland

    Background: Female haemophilia A carriers are at increased bleeding risk, but their bleeding symptoms are often underrecognised and undertreated. Clinical data on bleed management for these patients are limited. Improved, evidence-based guidelines are required for the treatment and management of women/girls with haemophilia A.

    Aims: To assess the perioperative efficacy and safety of simoctocog alfa (Nuwiq®) in women/girls with haemophilia A undergoing major elective surgery.

    Methods: NuDIMENSION is a phase 4, prospective, international, open-label, single-arm study. Women/girls aged ≥12 years, with mild or moderate haemophilia A (FVIII:C >1% – < 40%), scheduled to undergo major elective surgery, and with no current/past FVIII inhibitors are eligible. Simoctocog alfa will be administered once within 3 hours prior to surgery and repeated as necessary every 8–24 hours to achieve a FVIII plasma level of 80–100 IU/dL until adequate wound healing. Dosing with simoctocog alfa will continue for at least another 7 days, if required, to maintain a FVIII plasma level of 30–60 IU/dL (Figure 1). The primary endpoint is overall perioperative haemostatic efficacy (“success” or “failure”) of simoctocog alfa in women/girls with haemophilia A undergoing major surgery. Haemostatic efficacy will be assessed at the end of surgery and at the end of the postoperative period (i.e., up to 24 hours after the last injection of simoctocog alfa), with overall adjudication by an Independent Data Monitoring Committee. Safety endpoints will include incidence of thrombotic events and incidence of FVIII inhibitor formation.

    Results: This study is planned to start in Q2 2023 and aims to enrol 23 patients to document 26 major surgeries. It is intended to initiate NuDIMENSION at approximately 15 sites in USA and several European countries.

    Conclusion(s): Results from NuDIMENSION will add to evidence needed to develop specific treatment guidelines for bleed management in women/girls with haemophilia A.