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.
Sign the written informed consent form before enrollment;
Age ranging from 18 to 75 years old;
Be clinically diagnosed with primary immune thrombocytopenia for less than 3 months before randomization;
Have not received splenectomy or at least one first-line ITP treatment or emergency treatment in the past;
Suffering from other hematopoietic system diseases except ITP, including but not limited to leukemia, thrombocytopenia caused by tumor treatment, myeloproliferative diseases, multiple myeloma and myelodysplastic syndrome, etc.;
Having undergone splenectomy before the first administration;
Having received ITP drug treatment (including emergency treatment) before the first administration;
Having used drugs with c-Mpl (thrombopoietin receptor) stimulating effects within 4 weeks before the first administration;
Parallel
Dexamethasone Combined with romiplostim N01
DrugDexamethasone (HD-DXM) at a dose of 40mg/d for 4 days constitutes one cycle. If there is no response on the 10th day, repeat it once. The administration can be either oral or intravenous. Meanwhile, romiplostim N01 is administered with an initial dose of 3µg/kg by subcutaneous injection once a week for up to 6 months.
Dexamethasone monotherapy
DrugDexamethasone (HD-DXM) 40mg/d × 4 days, one cycle. If there is no response on the 10th day, repeat once, administered either orally or intravenously.
The proportion of patients with continuous remission.
Continuous remission is defined as the maintenance of the therapeutic effect of patients for at least 6 months since achieving remission, without the need for additional ITP-specific treatment.
The total effective rate GR
The total effective rate GR = CR + R (Complete response CR, platelet count ≥ 100×10\^9/L, and no bleeding symptoms; Effective R, platelet count is between 30×10\^9/L and 100×10\^9/L, and at least doubles compared to the baseline value, and no bleeding symptoms).
The proportion of patients with the initial response (reaching the effective standard within one month of the start of treatment)
The total effective rate GR = CR + R (Complete response CR, platelet count ≥ 100×10\^9/L, and no bleeding symptoms; Effective R, platelet count is between 30×10\^9/L and 100×10\^9/L, and at least doubles compared to the baseline value, and no bleeding symptoms within one month).
The proportion of patients reaching the effective standard 3 months after the start of treatment.
The total effective rate GR = CR + R (Complete response CR, platelet count ≥ 100×10\^9/L, and no bleeding symptoms; Effective R, platelet count is between 30×10\^9/L and 100×10\^9/L, and at least doubles compared to the baseline value, and no bleeding symptoms within 3 month).
The proportion of patients reaching the effective standard 6 months after the start
The total effective rate GR = CR + R (Complete response CR, platelet count ≥ 100×10\^9/L, and no bleeding symptoms; Effective R, platelet count is between 30×10\^9/L and 100×10\^9/L, and at least doubles compared to the baseline value, and no bleeding symptoms within 6 month).
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Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
The Second Affiliated Hospital of Kunming Medical University
Collaborator
Weifang People's Hospital
Collaborator
Shenzhen Second People's Hospital
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
Changzhi Medical College
Collaborator
Affiliated Hospital of Nantong University
Collaborator
The First People's Hospital of Yunnan
Collaborator
The First Affiliated Hospital of Bengbu Medical University
Collaborator
Suining Central Hospital
Collaborator
The Second Affiliated Hospital of Dalian Medical University
Collaborator
North China University of Science and Technology
Collaborator
Guizhou Provincial People's Hospital
Collaborator
