Obizur EU PASS
Research type
Research Study
Full title
Prospective and retrospective, non-interventional study to evaluate the safety and effectivness of Obizur in real-life practice.
IRAS ID
261948
Contact name
Nicola Curry
Contact email
Sponsor organisation
Baxalta Innovations GmbH
Duration of Study in the UK
2 years, 5 months, 31 days
Research summary
Aim of this study is to describe the safety, utilization and effectiveness of Obizur in the treatment of bleeding episodes in patients with acquired haemophilia A in real-life clinical practice.\nAcquired heamophilia A is life threatening autoimmune disease in which non-haemophilic person develop autoimmune inhibitors directed against circulating blood coagulation factors, including factor VIII (FVIII). Obizur is biotechnologically manufactured part of FVIII and its use is based on rationale that Obizur temporarily replaces inhibited FVIII and it is sufficiently similar to human FVIII to have haemostatic effect, yet sufficiently different so as to be less susceptible to inactivation by circulating inhibitors. \nThis post-authorisation safety study will collect further information on hypersensitivity reactions, will routinely monitor thromboembolic events and dose dispensing errors. In addition it will also collect other adverse events, information on inhibitory antibodies to Obizur, potential lack of efficacy, according to clinical practice in participating sites. \n
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
19/YH/0225
Date of REC Opinion
9 Jul 2019
REC opinion
Favourable Opinion