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A Study of Romiplostim N01 as the First-line Treatment for Newly Diagnosed Adult Patients With ITP
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
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 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.
Official title: A Multicenter Interventional Study of Romiplostim N01 Combined With Glucocorticoids as the First-line Treatment for Newly Diagnosed Adult Patients With ITP
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
129
Start Date
2024-06-01
Completion Date
2026-08-30
Last Updated
2024-10-26
Healthy Volunteers
No
Conditions
Interventions
Dexamethasone Combined with romiplostim N01
Dexamethasone (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 once a week for up to 6 months.
Dexamethasone monotherapy
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.
Locations (1)
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, Tianjin Municipality, China