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

Ropeginterferon alpha-2b is a mono-PEGylated proline-interferon for the treatment of polycythemia vera (PV). This drug is used biweekly with a starting dose of 100 mu g (50 mu g if patients receiving hydroxyurea) and 50 mu g increments up to a maximum dose of 500 mu g. Increasing evidence indicates that patients can tolerate higher starting doses of ropeginterferon alpha-2b. This phase II trial utilizes 250 mu g as the starting dose, 350 mu g at week 2 and 500 mu g 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 alpha-2b in Chinese patients with PV utilizing the 250-350-500 mu g dosing schema. This study will be used to support the application of a biologics license for PV treatment in China.

Automated summary

This study evaluates the safety, efficacy, and molecular response of ropeginterferon alpha-2b in Chinese patients with PV using the 250-350-500 mu g dosing schema. The results will be used to support the application for a biologics license for PV treatment in China.