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A Study of Romiplostim N01 as the First-line Treatment for Newly Diagnosed Adult Patients With ITP

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研究单位： [1]Institute of Hematology & Blood Diseases Hospital, China [2]Chinese Academy of Medical Science and Blood Disease Hospital,Tianjin,Tianjin,China,300000 [3]The Second Affiliated Hospital of Kunming Medical University [4]Weifang People's Hospital [5]Shenzhen Second People's Hospital [6]The Affiliated Hospital of Qingdao University [7]Changzhi Medical College [8]Affiliated Hospital of Nantong University [9]The First People's Hospital of Yunnan [10]First Affiliated Hospital Bengbu Medical College [11]Suining Central Hospital [12]The Second Affiliated Hospital of Dalian Medical University [13]Affiliated Hospital of North China University of Science and Technology [14]Guizhou Provincial People's Hospital

关键词： ITP Romiplostim Continuous Remission

研究目的：

This study is a multicenter interventional research on the first-line treatment of newly diagnosed adult patients with immune thrombocytopenia (ITP) using romiplostim N01 in combination with glucocorticoids. The primary endpoint of this study is to assess the efficacy of romiplostim N01 combined with glucocorticoids in untreated newly diagnosed adult ITP patients after 6 months of administration. The subjects will be divided into the experimental group and the control group for treatment. Experimental group: Dexamethasone (HD-DXM) 40mg/d × 4 days, one cycle. If there is no response on the 10th day, repeat once, administered either orally or intravenously. Simultaneously, romiplostim N01 is administered at an initial dose of 3µg/kg, by subcutaneous injection, once a week, for a maximum of 6 months. Control group: Dexamethasone (HD-DXM) 40mg/d × 4 days, one cycle. If there is no response on the 10th day, repeat once, administered either orally or intravenously.