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

Jie JinAlbert QinLei ZhangWeihong ShenWei WangJingjing ZhangYaning LiDaoxiang WuZhijian Xiao
Published in: Future oncology (London, England) (2023)
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 100 μg (50 μg if patients receiving hydroxyurea) and 50 μg increments up to a maximum dose of 500 μg. Increasing evidence indicates that patients can tolerate higher starting doses of ropeginterferon α-2b. This phase II trial utilizes 250 μg as the starting dose, 350 μg at week 2 and 500 μg 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 250-350-500 μg dosing schema. This study will be used to support the application of a biologics license for PV treatment in China.
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