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;
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