Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2025-12-24 @ 2:51 PM
NCT ID:
NCT05087459
Eligibility Criteria:
Inclusion Criteria:
1. Be able to understand this study and be willing to abide by all research procedures and sign informed consent voluntarily before screening;
2. Male or female, at least 18 years old when signing informed consent;
3. The initial clinical diagnosis of hepatocellular carcinoma was confirmed, and the CNLC stages were IA and IB;
4. Before enrollment, baseline platelet count \< 75×10\^9/L and \> 30×10\^9/L;
5. Elective hepatectomy is proposed, including laparotomy or laparoscopic hepatectomy, except hepatectomy combined with splenectomy or radiofrequency ablation;
6. Child-pugh GRADE A;
7. HBsAg and/or anti-HCV positive;
8. Male patients who are infertile or who agree to use appropriate contraceptive methods from the beginning of screening until the completion of the post-treatment phase;
9. Women who have not undergone menopause or surgical sterilization need to agree to use highly effective contraception from the beginning of screening until the completion of the post-treatment phase;
10. According to the opinions of researchers, those who can meet the requirements of this study.
Exclusion Criteria:
1. Any diseases below: Solid malignancies other than hepatocellular carcinoma, blood system tumor, aplastic anemia, myelodysplastic syndrome, myelofibrosis, congenital thrombocytopenia, drug-induced thrombocytopenia, immune thrombocytopenia, need treatment of systemic infection (except viral hepatitis);
2. Always thrombosis or current or former state (such as cerebral infarction, myocardial infarction, angina pectoris, coronary artery carotid stenting and angioplasty, coronary artery bypass grafting, congestive heart failure, known to increase the risk of thromboembolic events of arrhythmias such as atrial fibrillation, pulmonary thromboembolism, deep vein thrombosis or diffuse intravascular coagulation syndrome).
3. A known history of hereditary prethrombotic syndrome (e.g., clotting factor V Leiden mutation, prothrombin G20210A mutation, or hereditary antithrombin III (ATIII) deficiency);
4. Transfusion of platelets or blood products containing platelets within 7 days prior to screening;
5. Use erythropoietin within 7 days before screening;
6. Rhil-11,rhTPO, TPO receptor agonists (such as Avatriprap, altrippal, or romistetine) or splenic embolization within 30 days prior to screening;
7. Use of any of the following drugs or treatments within 90 days prior to screening: chemotherapy, interferon preparations, radiation;
8. Patients requiring systemic chemotherapy, targeted therapy, immunotherapy, traditional Chinese herbal therapy or radiation therapy during the study period;
9. At screening time, hemoglobin level ≤9.0g/dL or ≥18.0g/dL in male patients and \> 15.0g/dL in female patients, and hematocrit in male ≥0.54 and female ≥0.45;
10. Bleeding score ≥2 at screening (according to the WHO Bleeding scale);
11. Pt-inr and APTT at screening were lower than 80% of the lower limit of normal range or higher than 120% of the upper limit of normal range;
12. Preoperative anticoagulant or antiplatelet therapy should not be suspended according to the standard (low-dose aspirin is allowed to continue);
13. Female subjects who are breast-feeding or pregnant at the time of screening, or who plan to become pregnant during the study period;
14. Known or suspected persistent alcohol or drug abuse;
15. Known allergy to Avatripopa or any of its excipients;
16. HIV infected persons;
17. Participate in another clinical study within 30 days prior to screening, using any exploratory drugs or devices;Allowed to participate in observational studies;
18. The investigator believes that the accompanying medical history may affect the subjects' safe completion of the study;
19. In the opinion of the investigator, there are any other factors that may not be suitable for inclusion or affect participation or completion of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05087459
Study Brief:
Protocol Section:
NCT05087459