Reduced Volume and Faster Infusion Rate of Activated Prothrombin Complex Concentrate: A Phase 3b/4 Trial in Adults with Hemophilia A with Inhibitors
Bülent Zülfikar,
Johnny Mahlangu,
Salim Mohamed Nekkal,
Cecil Ross,
Noppacharn Uaprasert,
Jerzy Windyga,
Carmen Escuriola Ettingshausen,
Bettina Ploder,
Aurelia Lelli,
Hanna T. Gazda
Affiliations
Bülent Zülfikar
Hereditary Bleeding Disorders Unit in Oncology Institute, Istanbul University, Istanbul, Turkey
Johnny Mahlangu
Department of Molecular Medicine and Haematology, Faculty of Health Sciences, University of the Witwatersrand and NHLS, Johannesburg, South Africa
Salim Mohamed Nekkal
CHU Isaad Hassani, Beni Messous, Algiers, Algeria
Cecil Ross
St John's Medical College Hospital, Bangalore, India
Noppacharn Uaprasert
Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand
Jerzy Windyga
Department of Hemostasis Disorders and Internal Medicine, Laboratory of Hemostasis and Metabolic Diseases, Institute of Hematology and Transfusion Medicine, Warsaw, Poland
Carmen Escuriola Ettingshausen
Haemophilia Centre Rhein Main, Frankfurt-Mörfelden, Germany
Bettina Ploder
Baxalta Innovations GmbH, a Takeda company, Vienna, Austria
Aurelia Lelli
PDT R&D Global Medical Affairs, Takeda Pharmaceuticals International AG, Zurich, Switzerland
Hanna T. Gazda
Takeda Development Center Americas, Inc., Cambridge, Massachusetts, United States
Background Activated prothrombin complex concentrate (aPCC) is indicated for bleed treatment and prevention in patients with hemophilia with inhibitors. The safety and tolerability of intravenous aPCC at a reduced volume and faster infusion rates were evaluated.