The goal of this clinical trial is to learn if romiplostim N01 works to treat severe primary immune thrombocytopenia in adults. It will also learn about the safety of romiplostim N01. The main question it aims to answer is:
TO evaluate the effectiveness of the combination treatment of glucocorticoids, gamma globulin and romiplostim N01 in patients with severe primary immune thrombocytopenia during the initial treatment period for one month.
Participants will:
Romiplostim N01, starting dose of 1 µg/kg, subcutaneous injection, given on the third day of IVIG, once a week, for up to one month.
IVIG, 400mg/kg/d, intravenous administration, continuous administration for 3-5 days.
Prednisone, 0.8mg/kg/d, taken orally or intravenously, for up to one month.
Participants must sign a written informed consent prior to enrollment;
Ages 18-75;
Platelet count <10×10^9/L with active bleeding or bleeding score ≥5;
No contraindications to the use of steroids, romiplostim, or IVIG, and willingness to receive these treatments;
Individuals with the following hematological disorders other than ITP, including but not limited to leukemia, thrombocytopenia caused by cancer treatment, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome;
Individuals with a history of thrombosis;
Pregnant or lactating individuals;
Individuals with severe cardiopulmonary insufficiency;
Single group
corticosteroids combined with immunoglobulin and romiplostim
DrugRomiplostim N01, starting dose of 1 µg/kg, subcutaneous injection, given on the third day of IVIG, once a week, for up to one month. IVIG, 400mg/kg/d, intravenous administration, continuous administration for 3-5 days. Prednisone, 0.8mg/kg/d, taken orally or intravenously, for up to one month.
The total effective rate of treatment for 30 days
GR = CR + R (Complete reaction CR, platelet count ≥ 100×10\^9/L, and no bleeding symptoms; Effective R, platelet count between 30×10\^9/L and 100×10\^9/L, and at least double the baseline value, and no bleeding symptoms)
Early (week) response rate R
Effective R, platelet count between 30×10\^9/L and 100×10\^9/L, and at least double the baseline value, and no bleeding symptoms
Early Complete Response Rate (CR)
Complete reaction CR, platelet count ≥ 100×10\^9/L, and no bleeding symptoms
Time to Reaction
Time of Starting Treatment Until Platelet Count ≥ 30×10\^9/L
Adverse events during treatment
evaluated using Version 5.0 of the "Common Terminology Criteria for Adverse Events(NCI CTC AE)"
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
Qilu Hospital of Shandong University
Collaborator
Institute of Hematology & Blood Diseases Hospital, China
Collaborator
The First Affiliated Hospital of Soochow University
Collaborator
