Romiplostim in primary immune thrombocytopenia that is persistent or chronic: phase III multicenter, randomized, placebo-controlled clinical trial in China
机构：[1]Henan Cancer Hospital/The Affiliated Cancer Hospital of Zhengzhou University, Zhenzhou, China河南省肿瘤医院[2]Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Wuhan, China华中科技大学同济医学院附属同济医院[3]The First Affiliated Hospital of Soochow University, Suzhou, China[4]Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China中山大学附属第二医院[5]Shenzhen Second People’s Hospital, Shenzhen, China[6]West China Hospital, Sichuan University, Chengdu, China四川大学华西医院[7]Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Tianjin, China[8]The Third Xiangya Hospital of Central South University, Changsha, China[9]The First Affiliated Hospital of Bengbu Medical College, Bengbu, China[10]The Second affiliated Hospital of Nanchang University, Nanchang, China[11]The Second Hospital of Jilin University, Jilin, China[12]Peking University Third Hospital, Beijing, China[13]Rui Jin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China[14]Shandong Provincial Hospital, Jinan, China[15]The Affiliated Hospital of Qingdao University, Qingdao, China[16]Second Affiliated Hospital of Kunming Medical University, Kunming, China[17]Qilu Hospital of Shandong University, Jinan, China[18]Tianjin Medical University General Hospital, Tianjin, China[19]The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China浙江大学医学院附属第一医院[20]Qinghai Provincial People`s Hospital, Xining, China[21]Peking University First Hospital, Beijing, China[22]Fujian Medical University Union Hospital, Fuzhou, China[23]Navy General Hospital PLA China, Beijing, China[24]Tangdu Hospital, Xi’an, China[25]First Affiliated Hospital of Kunming Medical University, Kunming, China昆明医科大学附属第一医院[26]The First Affiliated Hospital of Haerbin Medical University, Haerbin, China[27]Anhui Provincial Hospital, Hefei, China[28]Wuxi People`s Hospital, Wuxi, China[29]Kyowa Kirin China Pharmaceutical Co, Ltd, Beijing, China[30]Kyowa Kirin Co, Ltd, Tokyo, Japan[31]Chinese Academy of Medical Sciences & Peking Union Medical College Hospital, Beijing, China
Background: Multiple trials have confirmed that romiplostim could increase platelet count in individuals with primary immune thrombocytopenia (ITP), but no related study has assessed Chinese patients. Objectives: To assess the effectiveness of romiplostim as a second-line treatment of persistent or chronic ITP in Chinese adults. Methods: This phase III multicenter, randomized, placebo-controlled, double-blind, then open-label clinical trial (NCT02868099, CTR20150395) was conducted at 28 investigational sites in China. The patients were randomly assigned (3:1) to romiplostim (starting and maximum doses of 1 and 10 & mu;g/kg, respectively) or placebo for 9 weeks (double-blind period), followed by the open-label period (both groups administered romiplostim) to week 22. The primary endpoint was the time (in weeks) during which platelet counts were & GE;50 x 109/L in the double-blind period. Results: In this study, 202 patients (romiplostim, n = 151; placebo, n = 51) started the treatment. The median (range) numbers of weeks with platelet response after 6 weeks of treatment were 2 (0-6) and 0 (0-2) in patients administered romiplostim and placebo, respectively (P < .001). During the double-blind period, the proportions of patients with treatment-emergent adverse events were comparable between the romiplostim and placebo groups (82.8% vs 82.4%). The treatment-emergent adverse event with & GE;10% difference in incidence between these 2 groups was injection site bleeding (1.3% vs 11.8%). Conclusion: Romiplostim significantly increased the time with maintained platelet response in patients with persistent or chronic ITP in comparison with placebo. No new safety signal was observed. Trial registration: ClinicalTrials.gov, NCT02868099. www.chinadrugtrials.org.cn/ clinicaltrials.searchlist.dhtml, CTR20150395
第一作者机构：[1]Henan Cancer Hospital/The Affiliated Cancer Hospital of Zhengzhou University, Zhenzhou, China
通讯作者：
通讯机构：[31]Chinese Academy of Medical Sciences & Peking Union Medical College Hospital, Beijing, China[*1]Department of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China.
推荐引用方式(GB/T 7714)：
Hu Zhou,Jianfeng Zhou,Depei Wu,et al.Romiplostim in primary immune thrombocytopenia that is persistent or chronic: phase III multicenter, randomized, placebo-controlled clinical trial in China[J].RESEARCH AND PRACTICE IN THROMBOSIS AND HAEMOSTASIS.2023,7(5):doi:10.1016/j.rpth.2023.100192.
APA：
Hu Zhou,Jianfeng Zhou,Depei Wu,Liping Ma MM,Xin Du...&Yongqiang Zhao.(2023).Romiplostim in primary immune thrombocytopenia that is persistent or chronic: phase III multicenter, randomized, placebo-controlled clinical trial in China.RESEARCH AND PRACTICE IN THROMBOSIS AND HAEMOSTASIS,7,(5)
MLA：
Hu Zhou,et al."Romiplostim in primary immune thrombocytopenia that is persistent or chronic: phase III multicenter, randomized, placebo-controlled clinical trial in China".RESEARCH AND PRACTICE IN THROMBOSIS AND HAEMOSTASIS 7..5(2023)
