HTRS2025.O8C.3 Alfa-PROTECT: A Phase 3, Open-Label Study to Evaluate the Safety of Damoctocog Alfa Pegol in Previously Treated Children Aged 7 to <12 Years With Severe Hemophilia A
Articles > Article · 2025
Authors: Margareth C. Ozelo, Anthony K.C. Chan, Luciani Matteo, Heidi Glosli, Ramazan Kaan KAVAKLI, Nasrin Samji, Gregory Makris, Luciana C. Oliveira, Shveta Gupta, Guillermo Arbesú, Mauro Davoli, Maria Elisa Mancuso
Research and Practice in Thrombosis and Haemostasis, International, WoS, 2025, vol 9, pp 103155-103155
DOI: 10.1016/j.rpth.2025.103155
Summary
Background: The effectiveness of damoctocog alfa pegol for the prevention and treatment of bleeding in previously treated children with severe hemophilia A was demonstrated in the PROTECT VIII Kids trial (NCT01775618). Children aged < 12 years were excluded from damoctocog alfa pegol’s initial marketing authorization application because of observed loss of efficacy and/or hypersensitivity reactions occurring within the first 4 exposure days (EDs) in some children aged < 6 years due to an immune response to PEG.