Efficacy and safety of recombinant factor VIIa preparation (NovoSeven) for patients with congenital factor VII deficiency

秀次, 花房; 和成, 大山; 智, 渡辺; 謙, 榊原; 祐司, 平松; 玄二, 新福; 洋行, 高木; 公治, 佐藤; 秀明, 坂部; 浩, 中谷; 聡, 日笠; 暁宏, 澤田; 哲夫, 西川; 啓二朗, 伊藤; 脩, 高宮; 章, 吉岡

doi:10.2491/jjsth.17.695

Cited by 5 publications

(1 citation statement)

References 28 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…However, due to the rarity of congenital FVII deficiency, we believe it is vital to assess all available data to help facilitate treatment decisions by clinicians and patients. In addition, our study was conducted in a real-life setting in Japan, is one of the largest studies to date in Asia, and our results support previous reports from Japanese studies that rFVIIa is effective when used in routine clinical practice [24,25].…”

Section: Discussionsupporting

confidence: 87%

A multicenter, observational study to evaluate hemostasis following recombinant activated FVII treatment in patients in Japan with congenital factor VII deficiency

Seita

Kinai

2023

Blood Coagulation &Amp; Fibrinolysis

View full text Add to dashboard Cite

Reports describing symptoms and treatment of patients with congenital factor VII (FVII) deficiency frequently relate to patients in Europe, while only a small number describe data from Asian countries. This multicenter, prospective observational study (NCT01312636) collected data from 30 sites for 55% of patients registered in 2011 in Japan with congenital FVII deficiency treated with activated recombinant FVII (rFVIIa) for bleeding episodes and/or during surgery. The mean follow-up in 20 eligible patients was 11 months (range 1–49 months). Of 348 bleeding episodes in seven patients, 170 (48.9%) were intra-articular bleeding and 62 (17.8%) were menorrhagia, of which 92.9% (158/170) and 100% (62/62) were in patients with baseline factor VII activity 20 IU/dl or less, respectively. The hemostatic effect after rFVIIa treatment was rated as excellent, effective or partially effective for 45.7, 33.6 and 18.4% of 348 bleeding episodes. Overall, hemostasis for bleeding events and surgery was achieved in nearly 2 days, with the majority of patients receiving two doses or less. The hemostatic effect after the recommended dose (15–30 μg/kg) of rFVIIa was rapid and effective treatment for all categories of bleeding and surgical procedure. On the basis of data from routine clinical practice, no new safety signals were identified. Trial Registration NCT01312636

show abstract

Section: Discussionsupporting

confidence: 87%