A Study on the Treatment of CTIT of the Efficacy and Safety With Romiplostim N01 Compared to Recombinant Human Interleukin-11

Exclusion Criteria22

• \. Platelet values at screening or baseline were ≤10×10\^9/L；
• Participants with a history of any hematological malignancy，including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome；
• Participants had a history of chronic platelet or bleeding disorders，or screening for thrombocytopenia caused by causes other than CIT within the first 6 months, including but not limited to chronic liver disease, splenic hyperfunction, infection, and bleeding；
• Bone marrow invasion or metastasis;
• Have received pelvic and spinal radiation therapy, as well as bone field radiation therapy, or are currently/expected to receive radiation therapy within the three months prior to screening;
• Brain tumors or brain metastases;
• Screening for a history of severe cardiovascular disease within the first 6 months, such as congestive heart failure (NYHA heart function score III-IV), known arrhythmias that increase the risk of thromboembolism, such as atrial fibrillation, after coronary stent implantation, angioplasty, and coronary artery bypass grafting;
• Any history of arterial or venous thrombosis occurring within the first 6 months of screening;
• Screening for clinical manifestations of severe bleeding within the first two weeks, such as gastrointestinal or central nervous system bleeding;
• Neutrophil absolute value < 1.0 × 10\^9/L, hemoglobin < 80g/L, allowing the use of granulocyte colony-stimulating factors and red blood cells that comply with clinical norms EPO infusion therapy
• Significant abnormalities in liver function: patients without liver metastasis, ALT/AST>3ULN (upper limit of normal value), TBIL>3ULN； Patients with liver metastasis are present, ALT/AST≥5ULN，TBIL≥5ULN;
• Renal dysfunction: blood creatinine ≥ 1.5ULN or eGFR ≤ 60 ml/min (Cockcroft Gault formula);
• Received thrombopoietin receptor agonists, recombinant human thrombopoietin (rhTPO), or recombinant human interleukin-11 (rhIL-11) within 5 half-lives of the drug prior to screening. The maximum washout period calculated based on 5 half-lives of the drugs is: hetrombopag 8.4 days, avatrombopag 4 days, eltrombopag 6.7 days, lusutrombopag 6 days, romiplostim or romiplostim N01 29 days, rhTPO 9.7 days, rhIL-11 1.4 days;
• Received platelet transfusion within the first two weeks of randomization;
• Participants who are known or expected to be allergic or intolerant to Roxetine N01 or rhIL-11 excipients;
• HIV infected individuals;
• Pregnant or lactating women;
• Participants had medically known hereditary prethrombotic syndromes (e.g., clotting factor V Leiden mutation, prothrombin G20210A mutation, or hereditary antithrombin III (ATIII) deficiency);
• Participants were given a vitamin K antagonist within 7 days prior to screening (permitted drugs included low molecular weight heparin, Factor Xa inhibitors, or thrombin inhibitors);
• As assessed by the investigators, the participants had any concomitant medical history that could compromise the participants' safe completion of the study, such as unstable angina, renal failure on hemodialysis, or an active infection requiring intravenous antibiotics;
• Participated in any clinical study of any other investigational drug or device three months prior to screening;
• The researchers believe that participating in the trial poses a significant risk to the health or safety of the subjects, or other circumstances that may affect the efficacy evaluation;