Efficacy and safety of QL0911 in adult patients with chronic primary immune thrombocytopenia: A multicenter, randomized, double-blind, placebo-controlled, phase III trial.
Hu ZhouShouqing HanJie JinRuibin HuangXinhong GuoXuliang ShenBinghua WangXin WangHongxia YaoXin DuMeijuan HuangXuehong RanWei WangTonghua YangFeng ZhangChangcheng ZhengXuelan ZuoRong FuDa GaoZheng GeYing HanYujie LiXiaoyan KangYan ShiMing HouPublished in: Journal of translational internal medicine (2023)
QL0911 was well-tolerated and increased and maintained platelet counts in adults with ITP. QL0911, a biosimilar to romiplostim (Nplate®), may be a novel treatment option for patients with ITP who have failed or relapsed from first-line treatment in China. Ongoing studies will provide further data on long-term efficacy and safety in such patient populations.
Keyphrases
- phase iii
- double blind
- placebo controlled
- clinical trial
- phase ii
- open label
- study protocol
- phase ii study
- acute myeloid leukemia
- acute lymphoblastic leukemia
- electronic health record
- multiple myeloma
- diffuse large b cell lymphoma
- peripheral blood
- big data
- squamous cell carcinoma
- radiation therapy
- combination therapy
- rectal cancer
- case control
- genetic diversity
- locally advanced
- replacement therapy