BAY 81‐8973 Demonstrates Long‐Term Safety and Efficacy in Children With Severe Haemophilia A: Results From the LEOPOLD Kids Extension Study

OBJECTIVES: To report the long-term safety and efficacy of BAY 81-8973 in the LEOPOLD Kids extension phase. METHODS: Patients received BAY 81-8973 (25-50 IU/kg) at least twice weekly. The primary endpoint was safety, assessed in all patients who entered the extension phase (n = 82). Efficacy endpoints were assessed in patients without high-titre inhibitors/immune tolerance induction (n = 67).