A Phase 3, Multi-centre, Open-label, Extension Study to Investigate the Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of long-term use of SPD422
Safety will be determined by the changes from study baseline in clinical laboratory evaluations, vital signs, and electrocardiograms (ECGs) recorded as an AE if clinically relevant.
3, 6, 9 and 12 months
Osaka University Hospital
Japan: Pharmaceuticals and Medical Devices Agency