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:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT07043894
Eligibility Criteria:
Inclusion Criteria:
1. Voluntary participation with signed informed consent.
2. Aged 6-24 years, any gender.
3. ECOG performance status 0-2.
4. Histologically/cytologically confirmed non-myeloid malignancy requiring high-intensity chemotherapy with ≥1 myelosuppressive agent.
5. Patients with potential curative opportunity eligible for standard therapy.
6. Chemotherapy-induced thrombocytopenia (platelets \<75×10⁹/L).
7. Anticipated survival ≥8 months.
8. Planned ≥2 additional chemotherapy cycles (21-/28-day cycles).
9. Laboratory parameters meeting:
* Renal function: Cr ≤1.5×ULN; Ccr ≥55 mL/min.
* Hepatic function:
* Total bilirubin ≤1.5×ULN; ALT/AST ≤3×ULN;
* For liver metastasis/cholangiocarcinoma: bilirubin ≤3×ULN, transaminases ≤5×ULN.
10. No participation in other drug trials within 4 weeks.
11. Good compliance with efficacy/safety follow-up per protocol.
12. Absence of severe complications (e.g., active GI bleeding/perforation, jaundice, obstruction, non-cancer fever \>38°C).
13. Ability to comprehend and sign informed consent.
Exclusion Criteria:
1. Hematologic disorders (non-CIT etiology): AML, ITP, MDS, MPN, multiple myeloma, etc.
2. Non-CIT thrombocytopenia within 6 months (e.g., chronic liver disease, hypersplenism, infection, hemorrhage).
3. Known hypersensitivity to romiplostim N01 or excipients (cellulose-lactose, L-HPC, magnesium stearate, film coating).
4. Refractory cytopenias:
* Hemoglobin \<50 g/L despite RBC/EPO;
* ANC \<1.0×10⁹/L despite G-CSF.
5. Pelvic/spinal/large-field radiotherapy within 3 months.
6. Arterial/venous thrombosis within 3 months.
7. Severe cardiovascular disease (NYHA Class III-IV, arrhythmia with thromboembolic risk, post-CABG/stent) within 6 months.
8. Use of rhTPO, rhIL-11, or TPO-RAs (eltrombopag/avatrombopag/hetrombopag) within 2 weeks.
9. Investigator-assessed risks compromising safety/efficacy evaluation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
24 Years
Study:
NCT07043894
Study Brief:
Protocol Section:
NCT07043894