The aim of the study is to demonstrate non-inferiority of ANB-002 compared with preventive use of coagulation factor IX (FIX) in adult subjects with hemophilia B with FIX activity ≤2% and without FIX inhibitor. The study will have an open-label single-arm design.
Men diagnosed with hemophilia B aged 18 or older
FIX activity ≤2%
Absense of FIX inhibitor
≥150 previous exposure days of treatment with FIX concentrates
Any diseases of blood and hematopoietic organs other than hemophilia B
A history of any gene therapy, including ANB-002
Diagnosed HIV-infection, not controlled with anti-viral therapy
Active HBV or HCV infection