Condition: Primary Immune Thrombocytopenia · Sponsor: Institute of Hematology & Blood Diseases Hospital, China
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.
This description comes directly from the study's public registry record.
Lei Zhang, MD · +8613502118379 · zhanglei1@ihcams.ac.cn
Yunfei Chen, MD · +8618502220788 · chenyunfei@ihcams.ac.cn
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| Chinese Academy of Medical Science and Blood Disease Hospital | Tianjin, Tianjin Municipality, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06658834