Clinical Study of Recombinant Factor VIII (BL-160) in Hemophilia A Patients

Autor:	Michio Fujimaki, Asashi Tanaka, Eizo Kakishita, Katsuyuki Fukutake, Hidenaga Hama, Midori Shima, Yasuharu Nishida, Akira Shirahata, Juzo Matsuda, Hiromu Fukui
Rok vydání:	1993
Předmět:	Clinical study medicine.medical_specialty Bleeding episodes Pharmacokinetics business.industry hemic and lymphatic diseases Internal medicine medicine Phases of clinical research business Gastroenterology Recombinant factor viii Surgery
Zdroj:	Japanese Journal of Thrombosis and Hemostasis. 4:179-188
ISSN:	1880-8808 0915-7441
Popis:	Phase I and II clinical studies were performed to evaluate the safety, efficacy and pharmacokinetics of recombinant factor VIII (BL-160) in hemophilia A patients. Three and seven patients were enrolled in the phase I and phase II study respectively. The half life and recovery observed with recombinant factor VIII were comparable to those observed with plasma-derived factor VIII (Hemofil M). Forty-four bleeding episodes were treated with recombinant factor VIII during the phase II study, hemostatic effects were excellent in 39 and good in 5 bleeding episodes. There is no evidence of neoantigenicity resulting from potential contaminating proteins used in production steps. No adverse reactions were reported. These data indicate that recombinant factor VIII is safe and efficacious for the treatment of bleeding episodes in hemophilia A.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::8cea7f37ba4269c17c515455a09f4c64 https://doi.org/10.2491/jjsth.4.179 Zobrazit plný text záznamu