EFFICACY AND SAFETY OF MOROCTOCOG ALFA IN AN OPEN, MULTICENTER, PROSPECTIVE, CLINICAL STUDY IN CHILDREN 2 TO 6 YEARS OF AGE WITH SEVERE HEMOPHILIA A

Autor:	A.Yu. Borozinets, E.V. Gapchenko, K.G. Kopylov, S.N. Farafonova, M.A. Timofeeva, E.E. Shiller, V.V. Lebedev, Immunology named after Dmitry Rogachev, Moscow, Russia, N.I. Zozulya, Dmitry Kudlay, V.M. Chernov, E.P. Ivashkina, O.I. Plaksina, T.V. Asekretova, O.A. Markova
Rok vydání:	2021
Předmět:	Pediatrics medicine.medical_specialty business.industry Pediatrics Perinatology and Child Health Prospective clinical study medicine Moroctocog alfa Severe hemophilia A business
Zdroj:	Pediatria. Journal named after G.N. Speransky. 100:154-161
ISSN:	1990-2182 0031-403X
DOI:	10.24110/0031-403x-2021-100-6-154-161
Popis:	The purpose of the study was to assess the efficacy, safety and pharmacokinetics of the moroctocog alfa (Octofactor) in children aged 2-6 with haemophilia A. Materials and methods of research : six patients between 2 and 6 years of age (average age 4.3±0.8 years) were included in the open multicenter prospective clinical trial. The efficacy of the drug was assessed against the background of the introduction of 30±10 IU/kg every 2–3 days, the safety was assessed by the frequency and causality of adverse reactions. Results: 7 post-traumatic bleeding was registered. The average prophylactic dose of the drug is 37.84±7.13 IU/kg. The dose of the drug for stopping bleeding was 1000 IU. 2 adverse events have been reported that are not related to moroсtocog alfa. Conclusion: the obtained data indicate the efficacy and safety of moroсtocog alfa in the study group of patients.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::c78db7afa429209d8213bce87eb5b84f https://doi.org/10.24110/0031-403x-2021-100-6-154-161 Zobrazit plný text záznamu