Hu Zhou, Shouqing Han, Jie Jin, Ruibin Huang, Xinhong Guo, Xuliang Shen, Binghua Wang, Xin Wang, Hongxia Yao, Xin Du, Meijuan Huang, Xuehong Ran, Wei Wang, Tonghua Yang, Feng Zhang, Changcheng Zheng, Xuelan Zuo, Rong Fu, Da Gao, Zheng Ge, Ying Han, Yujie Li, Xiaoyan Kang, Yan Shi, Ming Hou
OBJECTIVE: QL0911, a recombinant human thrombopoietin mimetic peptide-Fc fusion protein, is a romiplostim (Nplate® ) biosimilar used to treat primary immune thrombocytopenia (ITP). This phase III study aimed to assess the efficacy and safety of QL0911 in adult patients with chronic primary ITP over a 24-week treatment period. METHODS: We conducted a double-blind, placebo-controlled, phase III study in patients diagnosed with primary ITP for at least 12 months who had received at least one first-line ITP treatment with no response or recurrence after treatment, or who relapsed after splenectomy at 44 sites in China...
December 2023: Journal of Translational Internal Medicine