A Study of Romiplostim N01 as the First-line Treatment for Newly Diagnosed Adult Patients With ITP
Status:
RECRUITING
Trial end date:
2026-08-30
Target enrollment:
Participant gender:
Summary
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 3g/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.
Phase:
PHASE2
Details
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Collaborators:
Affiliated Hospital of Nantong University Changzhi Medical College Guizhou Provincial People's Hospital North China University of Science and Technology Shenzhen Second People's Hospital Suining Central Hospital The Affiliated Hospital of Qingdao University The First Affiliated Hospital of Bengbu Medical University The First People's Hospital of Yunnan The Second Affiliated Hospital of Dalian Medical University The Second Affiliated Hospital of Kunming Medical University Weifang People's Hospital