FEIBA NF GLOBAL OUTCOME STUDY
Baxalta Innovations GmbH
Duration of Study in the UK
5 years, 4 months, 29 days
The study addresses the need to measure long-term effectiveness, safety and quality of life outcome measures for haemophilia A or B patients with high-responding inhibitors treated on-demand and in prophylaxis with FEIBA NF [Anti-Inhibitor Coagulant Complex].
The purpose of the study is to document the natural history of haemophilia A or B disease in subjects with high responding inhibitors either to Factor VIII or Factor IX and to describe long-term outcomes in terms of effectiveness, safety and quality of life in subjects receiving FEIBA NF in routine clinical practice.
East Midlands - Nottingham 1 Research Ethics Committee
Date of REC Opinion
31 Jul 2015
Further Information Favourable Opinion