Efficacy and Safety of QL0911 in Adult Patients With Chronic Primary Immune Thrombocytopenia

Summary

QL0911, a recombinant human thrombopoietin mimetic peptide-Fc fusion protein for injection, is a romiplostim (Nplate®) biosimilar for the treatment of primary immune thrombocytopenia (ITP). This phase III study aimed to assess the efficacy and safety of QL0911 in adult patients with primary chronic ITP.

Timeline

Start

2019-10-18

Primary completion

2021-12-13

Completion

2021-12-16

Publications

• Zhou H, Han S, Jin J, Huang R, Guo X, Shen X, Wang B, Wang X, Yao H, Du X, Huang M, Ran X, Wang W, Yang T, Zhang F, Zheng C, Zuo X, Fu R, Gao D, Ge Z, Han Y, Li Y, Kang X, Shi Y, Hou M. Efficacy and safety of QL0911 in adult patients with chronic primary immune thrombocytopenia: A multicenter, randomized, double-blind, placebo-controlled, phase III trial. J Transl Int Med. 2023 Dec 20;11(4):423-432. doi: 10.2478/jtim-2023-0106. eCollection 2023 Dec.

Drugs

Indications