Chemotherapy-Induced Thrombocytopenia
Conditions
Interventions
experimental group:The subjects were injected with Romiplostin N01 (3 µg/kg) once a week until the completion of two consecutive chemotherapy cycles.
Sponsors
Nanjing Drum Tower Hospital Suqian Branch
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Participants voluntarily joined this study, signed the informed consent form, and strictly followed the requirements of the research protocol; 2. Male or female, aged 18 to 75 years; 3. Diagnosed with malignant tumors through pathological histology and/or cytology, and currently receiving anti-tumor treatments such as chemotherapy, radiotherapy, immunotherapy, and targeted therapy; 4. ECOG PS score 0-2; 5. Experienced tumor treatment-induced thrombocytopenia, and required two platelet tests, with an interval of 24 hours, and 10×10^9/L = 12 weeks, and able to receive the current anti-tumor treatment for at least one cycle or more; 7. Participants of childbearing age, agreed to take reliable contraceptive measures throughout the study (including male or female condoms, contraceptive foam, contraceptive gel, contraceptive film, contraceptive cream, contraceptive plug, abstinence, and intrauterine device placement); Excluding participants who have undergone hysterectomy, bilateral fallopian tube resection, bilateral fallopian tube ligation, or have been post-menopausal for more than one year, and participants with bilateral vas deferens resection or ligation; 8. Sufficient organ and bone marrow functions.
Exclusion criteria
Exclusion criteria: 1. Filter or baseline platelet value 3ULN (upper limit of normal), TBIL > 3ULN; patients with liver metastasis, ALT/AST >= 5ULN, TBIL >= 5ULN; 11. Abnormal renal function: serum creatinine >= 1.5ULN or eGFR <= 60ml/min (Cockcroft-Gault formula); 12. Within the past 1 month, participants have received drugs of thrombopoietin receptor agonists (such as eculizumab, avacopromab, eltrombopag, ropizumab) or human recombinant thrombopoietin (rhTPO), or recombinant human interleukin-11 (rhIL-11) treatment; 13. Participants received platelet transfusion within 2 weeks before randomization; 14. Participants known or expected to be intolerant to ropizumab N01 or rhIL-11; 15. HIV-infected individuals; 16. Participants who are in the lactation period or pregnancy at the time of screening (proven by positive serum ß-human chorionic gonadotropin [ß-hCG] test) or during the baseline visit (urine); 17. Participants with a known genetic thrombotic pre-syndrome (such as factor V Leiden mutation, prothrombin G20210A mutation, or hereditary antithrombin III (ATIII) deficiency); 18. Participants used vitamin K antagonists within 7 days before screening (allowing the use of low molecular weight heparin, factor Xa inhibitors or thrombin inhibitors); 19. According to the investigator's assessment, participants have any concomitant medical history that may compromise their safety in completing the study, such as unstable angina pectoris, renal failure due to hemodialysis or active infection requiring intravenous antibiotics; 20. Participants have participated in any other clinical study of investigational drugs or devices within the past 3 months before screening; 21. Other situations that the investigator considers to pose a significant risk to the participant's health or safety, or may affect the efficacy assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with effective treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in platelet count;Incidence of bleeding events;Severity; | — |
Countries
China
Contacts
Public ContactGuangqi Wu
Nanjing Gulou Hospital Group Suqian Hospital
Outcome results
None listed