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;
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