Design of an international, phase IV, open-label study of simoctocog alfa in women/girls with hemophilia A undergoing surgery (NuDIMENSION)

Although hemophilia A mainly affects males, carriers (defined as females with hemophilia A, as well as symptomatic or asymptomatic hemophilia A carriers) are at risk of excessive bleeding, particularly during trauma or during surgical procedures. Clinical trials have focused on male patients with se...

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Published in:Therapeutic advances in hematology 2024-01, Vol.15, p.20406207241300040
Main Authors: Marquardt, Natascha, Langer, Florian, Holstein, Katharina, Álvarez Román, María Teresa, Núñez Vázquez, Ramiro, Miljić, Predrag, Drillaud, Nicolas, Ardillon, Laurent, Lehtinen, Anna-Elina, Santoro, Rita Carlotta, Napolitano, Mariasanta, Siragusa, Sergio, Gidley, Gillian, Jansen, Martina, Knaub, Sigurd, Oldenburg, Johannes
Format: Article
Language:English
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Study Protocol
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Summary:Although hemophilia A mainly affects males, carriers (defined as females with hemophilia A, as well as symptomatic or asymptomatic hemophilia A carriers) are at risk of excessive bleeding, particularly during trauma or during surgical procedures. Clinical trials have focused on male patients with severe disease, and data for females are limited. Improved, evidence-based treatment guidelines for management of hemophilia A carriers are required. The NuDIMENSION study is a phase IV, prospective, open-label, single-arm study that will evaluate the perioperative efficacy and safety of simoctocog alfa (Nuwiq ), a recombinant factor VIII (FVIII), in women/girls with hemophilia A undergoing major surgery. The study will be conducted at approximately 15 centers worldwide. Women/girls aged ⩾12 years, with mild or moderate hemophilia A (residual FVIII activity (FVIII:C) ⩾1% to
ISSN:2040-6207
2040-6215
DOI:10.1177/20406207241300040