A phase II trial to assess the efficacy and safety of ropeginterferon α-2b in Chinese patients with polycythemia vera.

Abstract

Ropeginterferon α-2b is a mono-PEGylated proline-interferon for the treatment of polycythemia vera (PV). This drug is used biweekly with a starting dose of 100μg (50 μg if patientsreceiving hydroxyurea)and 50μg increments up to a maximum dose of500μg. Increasing evidence indicates that patients can tolerate higher starting doses of ropeginterferon α-2b. This phase II trial utilizes 250μg as the starting dose, 350μg at week 2 and 500μg at week 4 as the target dose. Doses can be adjusted according to tolerability. This study assesses the safety, efficacy and molecular response of ropeginterferon α-2b in Chinese patients with PV utilizing the 250-350-500μg dosing schema. This study will be used to support the application of a biologics license for PV treatment in China.