A Study to Access Efficacy and Safety of P1101 in Chinese PV Patients Who Are Intolerant or Resistance to HU

Summary

This study is a phase II single-arm study designed to evaluate the efficacy and safety of P1101 in Chinese PV patients who are intolerance or resistance to HU.

Timeline

Start

2021-10-08

Primary completion

2022-09-07

Completion

2027-07

Publications

• Qin A, Shimoda K, Suo S, Fu R, Kirito K, Wu D, Liao J, Chen H, Wu L, Su X, Gao Y, Sato T, Li Y, Zhang J, Shen W, Wang W, Zhang L, Jin J, Komatsu N. Population Pharmacokinetics-Pharmacodynamics and Exposure-Response of Ropeginterferon Alfa-2b in Chinese and Japanese Patients With Polycythemia Vera. Pharmacol Res Perspect. 2025 Jun;13(3):e70109. doi: 10.1002/prp2.70109.
• Jin J, Zhang L, Qin A, Wu D, Shao Z, Bai J, Chen S, Duan M, Zhou H, Xu N, Zhang S, Zuo X, Du X, Wang L, Li P, Zhang X, Li Y, Zhang J, Wang W, Shen W, Zagrijtschuk O, Urbanski R, Sato T, Xiao Z. A new dosing regimen of ropeginterferon alfa-2b is highly effective and tolerable: findings from a phase 2 study in Chinese patients with polycythemia vera. Exp Hematol Oncol. 2023 Jun 21;12(1):55. doi: 10.1186/s40164-023-00415-0.
• Jin J, Qin A, Zhang L, Shen W, Wang W, Zhang J, Li Y, Wu D, Xiao Z. A phase II trial to assess the efficacy and safety of ropeginterferon alpha-2b in Chinese patients with polycythemia vera. Future Oncol. 2023 Apr;19(11):753-761. doi: 10.2217/fon-2022-1141. Epub 2023 May 2.

Drugs

Indications