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 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT06036966
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-75 years;
2. Ovarian cancer patients using niraparib as maintenance therapy;
3. Estimated survival≥ 12 weeks;
4. Eastern Cooperative Oncology Group Physical Score(ECOG PS) : 0-2;
5. Adequate function of organs:
(1) Platelet count 100-300\*109/L, neutrophil count≥2.0\*109/L, hemoglobin 100-150g/L; (2) Renal function: Cr≤1.5 upper limit of normal（ULN）; (3) Endogenous creatinine clearance (Ccr) ≥ 55 ml/min; (4) Liver function: total bilirubin ≤1.5 upper limit of normal（ULN）; (5) Alanine aminotransferase（ALT）and aspartate aminotransferase（AST）≤3 upper limit of normal（ULN）; (6) Coagulation function: PT≤1.5 upper limit of normal（ULN）; 6. No serious complications (including active gastrointestinal bleeding, perforation, jaundice, gastrointestinal obstruction, non-cancerous fever\> 38℃)
Exclusion Criteria:
1. Patients with the following hematopoietic system diseases: leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma and myelodysplastic syndrome, etc;
2. Thrombocytopenia caused by non-anti-tumor therapy within 6 months before screening, including chronic liver disease, hypersplenism, infection and bleeding, etc;
3. Imaging examination shows bone marrow invasion or bone marrow metastasis, such as Positron Emission Computed Tomography（PET-CT）, Magnetic Resonance Imaging（MRI）or nuclear scan;
4. Patients with antiphospholipid syndrome;
5. Platelet transfusion or used TPO-RA, rhTPO and other platelet-raising drugs within 3 days before screening;
6. Patients with known or expected hypersensitivity or intolerance to the active ingredient or excipients of Hetrombopag
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06036966
Study Brief:
Protocol Section:
NCT06036966