This prospective, multicenter, randomized study aim to evaluate the efficacy and safety of romiplostim N01 combined with glucocorticoids as the first-line treatment for newly diagnosed adult primary immune thrombocytopenia (ITP).
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 any prior treatments for ITP.
Suffering from other secondary thrombocytopenia except ITP, including but not limited to leukemia, thrombocytopenia caused by tumor treatment, myeloproliferative diseases, multiple myeloma, myelodysplastic syndrome, common variable immunodeficiency, and hereditary thrombocytopenia, 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
Romiplostim N01 combined with dexamethasone
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 within 4 days of dexamethasone treatment 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 OR
The total effective rate OR = CR + R (Complete response CR, platelet count ≥ 100×10\^9/L, and no bleeding symptoms; Response 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 OR = CR + R (Complete response CR, platelet count ≥ 100×10\^9/L, and no bleeding symptoms; Response 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 OR = CR + R (Complete response CR, platelet count ≥ 100×10\^9/L, and no bleeding symptoms; Response 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 OR = CR + R (Complete response CR, platelet count ≥ 100×10\^9/L, and no bleeding symptoms; Response 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
Weifang People's Hospital
Collaborator
Shenzhen Second People's Hospital
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
Affiliated Hospital of Nantong University
Collaborator
The First Affiliated Hospital of Bengbu Medical University
Collaborator
The Second Affiliated Hospital of Dalian Medical University
Collaborator
Affiliated Hospital of North Sichuan Medical College
Collaborator
Changzhi Medical College
Collaborator
North China University of Science and Technology
Collaborator
Tianjin Hospital of ITCWM-Nankai Hospital
Collaborator
Baoding First Central Hospital
Collaborator
