A multicenter, observational study to evaluate hemostasis following recombinant activated FVII treatment in patients in Japan with congenital factor VII deficiency.
Blood Coagul Fibrinolysis
; 34(5): 295-304, 2023 Jul 01.
Article
de En
| MEDLINE
| ID: mdl-37395185
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 20âIU/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 (15-30âµg/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.
Texte intégral:
1
Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Hémostatiques
/
Déficit en facteur VII
Type d'étude:
Clinical_trials
/
Etiology_studies
/
Observational_studies
/
Prognostic_studies
Limites:
Female
/
Humans
Pays/Région comme sujet:
Asia
Langue:
En
Journal:
Blood Coagul Fibrinolysis
Sujet du journal:
ANGIOLOGIA
/
HEMATOLOGIA
Année:
2023
Type de document:
Article
Pays de publication:
Royaume-Uni