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A Study of Romiplostim N01 as the First-line Treatment for Newly Diagnosed Adult Patients With ITP

StatusUnknown
PhasePhase 2
Started2024-06-01
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 26, 2024 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2026-09-06
minor
Trial status changed: Recruiting → Unknown
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.
Trial Details
NCT Number NCT06658834
Lead Sponsor Institute of Hematology & Blood Diseases Hospital, China
Collaborators: The Second Affiliated Hospital of Kunming Medical University, Weifang People's Hospital, Shenzhen Second People's Hospital, The Affiliated Hospital of Qingdao University, Changzhi Medical College, Affiliated Hospital of Nantong University, The First People's Hospital of Yunnan, The First Affiliated Hospital of Bengbu Medical University, Suining Central Hospital, The Second Affiliated Hospital of Dalian Medical University, North China University of Science and Technology, Guizhou Provincial People's Hospital
Conditions Primary Immune Thrombocytopenia
Enrollment 129 participants
Start Date 2024-06-01
Primary Completion 2025-06-30 (estimated)
Study Completion 2026-08-30 (estimated)
Updated on ClinicalTrials.gov 2024-10-26