RESULTS OF OPEN, PROSPECTIVE, MULTICENTER, NON-COMPARATIVE STUDY OF NONACOG ALPHA PHARMACOKINETICS, EFFICACY AND SAFETY IN CHILDREN AGED 2–12 YEARS WITH SEVERE AND MODERATE HEMOPHILIA В
Authors:   Saint Petersburg City Polyclinic No. 37, Saint Petersburg, Russia, Andreeva T.A. , Lebedev V.V. ,   Krasnodar Krai Regional Children's Clinical Hospital, Krasnodar, Krasnodar Krai, Russia, Vdovin V.V. ,   Morozov Children’s City Clinical Hospital, Moscow, Russia, Timofeeva M.A. ,   Kirov Research Institute of Hematology and Blood Transfusion, Kirov, Russia, Davydkin I.L. ,   Samara State Medical University, Samara, Russia, Lavrichenko I.A. ,   Saint Petersburg City Polyclinic No. 37, Saint Petersburg, Russia, Krasheninnikova O.A. ,   Saint Petersburg City Polyclinic No. 37, Saint Petersburg, Russia, Asekretova T.V. ,   Krasnodar Krai Regional Children's Clinical Hospital, Krasnodar, Krasnodar Krai, Russia, Shkryabunova V.V. ,   Krasnodar Krai Regional Children's Clinical Hospital, Krasnodar, Krasnodar Krai, Russia, Svirin P.V. ,   Morozov Children’s City Clinical Hospital, Moscow, Russia, Petrov V.Yu. ,   Morozov Children’s City Clinical Hospital, Moscow, Russia, Lavrentieva I.N. ,   Morozov Children’s City Clinical Hospital, Moscow, Russia, Kurtov I.V. ,   Samara State Medical University, Samara, Russia, Shiller E.E. ,   Odintsovo Regional Hospital, Odintsovo, Moscow Oblast, Russia, Tarasova I.S. ,   National Scientific and Practical Center for Pediatric Hematology, Oncology and Immunology named after Dmitry Rogachev, Moscow, Russia, Kudlay D.A. ,   GENERIUM, JSC, Pharmaceutical Company, Volginsky, Petushinsky District, Vladimir Oblast, Russia,   I.M. Sechenov First Moscow State Medical University, Moscow, Russia, Gapchenko E.V. ,   GENERIUM, JSC, Pharmaceutical Company, Volginsky, Petushinsky District, Vladimir Oblast, Russia, Markova O.A. ,   GENERIUM, JSC, Pharmaceutical Company, Volginsky, Petushinsky District, Vladimir Oblast, Russia, Borozinets A.Yu. ,   GENERIUM, JSC, Pharmaceutical Company, Volginsky, Petushinsky District, Vladimir Oblast, Russia
Published: January 2022

The aim of the study was to evaluate the efficacy, safety and pharmacokinetics of nonacog alfa (Innonafactor) in children aged 2 to 12 years with hemophilia B. Materials and methods: 15 patients (7.7±2.5 years ) were included in an open, multicenter, prospective, non-comparative clinical trial, of whom 12 were aged 6 to 12 years and 3 were aged 2 to 6 years. The efficacy of the drug was assessed against the background of the introduction of 45±10 IU/kg 2 times a week with an interval of 72–96 hours, the safety was assessed by the frequency and nature of adverse reactions. Results: 5 (22%) spontaneous and 18 (78%) post-traumatic bleedings were registered. The mean number of spontaneous bleeding within 72 hours after administration of nonacog alfa was 2±1.4. The average prophylactic dose was 47.74±6.47 IU/kg (Me 48.2 IU/kg). An average of 2.2±2.1 injections was required to stop a bleeding episode. 19 adverse events have been reported that are not related to nonacog alfa. Conclusion: the obtained data indicate the efficacy and safety of nonacog alfa in the study group of patients. Thus, the data obtained indicate the efficacy and safety of Innonafactor drug both for prophylactic treatment and for the relief of bleeding in patients aged 2 to 12 years with severe and moderate hemophilia B.