Nirmalkumar Choraria, Savita Rangarajan, M Joseph John, Shashikant Apte, Pritam Gupta, Seema Pai, Rohit Chand, Shyam Parvatini, G S H Ramakanth, Jeremy Rupon, Amit Chhabra, Hitesh Bhaskarrao Muley, Damien Simoneau
PURPOSE: Hemophilia B is an X-linked congenital bleeding disorder caused by a deficiency of coagulation factor IX (FIX) clotting activity. This study evaluated safety and efficacy of nonacog alfa, a recombinant human blood coagulation FIX replacement product, in males aged 12-65 years with hemophilia B (FIX activity ≤ 2%) with or without inhibitors in India. METHODS: In this multicenter, open-label, post-approval phase 4 study, participants were treated for up to 8 weeks, with up to a 4-week screening period and a subsequent post-treatment 28-day safety observation period...
October 2023: Indian Journal of Hematology & Blood Transfusion