Chemotherapy-Induced Thrombocytopenia
Conditions
Interventions
Sponsors
Anhui provincial hospital (The First Affiliated Hospital of University of Science and Technology of China)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Sign a written informed consent form before joining the group; 2) Age >= 18 years old; 3) Breast cancer or gynecological tumor confirmed by histology or pathology; 4) CTIT patients induced by paclitaxel based chemotherapy regimen; 5) Platelet count<50 × 10^9/L; 6) The patient has not previously received treatment with Lopsidine N01; 7) ECOG score: 0-3; 8) The subjects of childbearing age agreed to take reliable contraceptive measures (including male or female condoms, contraceptive foam, contraceptive gel, contraceptive film, contraceptive cream, contraceptive suppository, abstinence and IUD placement) throughout the study period; 9) Researchers believe that patients who can benefit.
Exclusion criteria
Exclusion criteria: 1) Suffering from other hematopoietic system diseases, including leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, myelodysplastic syndrome, etc., except for breast cancer and thrombocytopenia caused by chemotherapy with paclitaxel in gynecology; 2) Screening for thrombocytopenia caused by non tumor therapy within the first 6 months, including but not limited to cirrhosis, splenic hyperfunction, infection, bleeding, etc; 3) History of severe cardiovascular disease within 6 months prior to screening, such as congestive heart failure (NYHA heart function score III-IV), arrhythmias known to increase the risk of thromboembolism, such as atrial fibrillation, coronary stent implantation, angioplasty, and coronary artery bypass grafting; 4) History of arterial or venous thrombosis within 6 months prior to screening; 5) Severe bleeding within 7 days prior to screening (requiring more than 2 units of red blood cell transfusion or a sudden drop in hematocrit of >= 10%); 6) Within the 7 days prior to screening, have used other thrombopoietin receptor agonists, recombinant human thrombopoietin, or interleukin-11 therapy; 7) Patients who are known or expected to be allergic or intolerant to Lopsidine N01 excipient; 8) HIV infected individuals; 9) Pregnant or lactating women; 10) Patients with cognitive impairment or uncontrolled mental illness; 11) Have participated in any other clinical studies of unlisted drugs or devices in the 28 days prior to screening; 12) Researchers believe that participating in the trial poses significant risks to the health or safety of participants, or other situations that may affect the evaluation of efficacy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median time required for PLT to recover to >= 100 × 10^9/L after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with PLT >= 50 × 10^9/L 2 weeks after treatment;Proportion of patients who respond within 7 days of treatment (response criteria: no need for platelet transfusion and PLT elevation = 50 × 109/L);The time required for PLT to recover to >= 50 × 10^9/L after receiving treatment;The lowest platelet count from the beginning of treatment to the end of treatment;Proportion of patients receiving platelet transfusion;Incidence of adverse reaction events; | — |
Countries
China
Contacts
Public ContactHan Xinghua
Anhui provincial hospital(The First Affiliated Hospital of University of Science and Technology of China)
Outcome results
None listed