[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596318":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":29,"responsibleParty":45,"collaborators":19,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":19,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":19,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":19,"overallStatus":32,"whyStopped":19,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Romiplostim N01","EXPERIMENTAL","Participants receive weekly subcutaneous injections of romiplostim N01 (250 μg\u002Fvial; Qilu Pharmaceutical) starting at 2 μg\u002Fkg.",[13],"Drug: Romiplostim N01",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Participants receive weekly subcutaneous injections of romiplostim N01 (250 μg\u002Fvial; Qilu Pharmaceutical) starting at 2 μg\u002Fkg. Doses are adjusted weekly based on platelet counts: increased by 2 μg\u002Fkg if platelets are \\\u003C50 × 10⁹\u002FL, by 1 μg\u002Fkg if 50-99 × 10⁹\u002FL, up to a maximum of 10 μg\u002Fkg. Treatment continues for up to 2 weeks but stops early if platelets reach ≥100 × 10⁹\u002FL or increase by ≥30 × 10⁹\u002FL from baseline.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Sidan Li","PRINCIPAL_INVESTIGATOR",[25],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},"CONTACT","+86-0316-5917421","lisidan2006@126.com",[30],{"facility":31,"status":32,"city":33,"state":19,"zip":19,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Cancer Hospital, Chinese Academy of Medical Sciences","RECRUITING","Beijing","China","CN",{"type":37,"coordinates":38},"Point",[39,40],116.39723,39.9075,{"lat":40,"lon":39},[43],{"name":22,"role":26,"phone":44,"phoneExt":19,"email":28},"+86-010-87788559",{"type":23,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"SIDAN LI","Prof","100596318","phase-2-romiplostim-n01-for-chemotherapy-induced-thrombocytopenia-in-pediatric-cancer-patients-100596318",false,"NCT07043894","Romiplostim N01 for Chemotherapy-Induced Thrombocytopenia in Pediatric Cancer Patients","A Prospective, Multicenter Study on the Efficacy and Safety of Romiplostim N01 for Chemotherapy-Induced Thrombocytopenia (CIT) in Children, Adolescents, and Young Adults (CAYA) With Hematological and Solid Tumors","Inclusion Criteria:\n\n1. Voluntary participation with signed informed consent.\n2. Aged 6-24 years, any gender.\n3. ECOG performance status 0-2.\n4. Histologically\u002Fcytologically confirmed non-myeloid malignancy requiring high-intensity chemotherapy with ≥1 myelosuppressive agent.\n5. Patients with potential curative opportunity eligible for standard therapy.\n6. Chemotherapy-induced thrombocytopenia (platelets \\\u003C75×10⁹\u002FL).\n7. Anticipated survival ≥8 months.\n8. Planned ≥2 additional chemotherapy cycles (21-\u002F28-day cycles).\n9. Laboratory parameters meeting:\n\n   * Renal function: Cr ≤1.5×ULN; Ccr ≥55 mL\u002Fmin.\n   * Hepatic function:\n\n     * Total bilirubin ≤1.5×ULN; ALT\u002FAST ≤3×ULN;\n     * For liver metastasis\u002Fcholangiocarcinoma: bilirubin ≤3×ULN, transaminases ≤5×ULN.\n10. No participation in other drug trials within 4 weeks.\n11. Good compliance with efficacy\u002Fsafety follow-up per protocol.\n12. Absence of severe complications (e.g., active GI bleeding\u002Fperforation, jaundice, obstruction, non-cancer fever \\>38°C).\n13. Ability to comprehend and sign informed consent.\n\nExclusion Criteria:\n\n1. Hematologic disorders (non-CIT etiology): AML, ITP, MDS, MPN, multiple myeloma, etc.\n2. Non-CIT thrombocytopenia within 6 months (e.g., chronic liver disease, hypersplenism, infection, hemorrhage).\n3. Known hypersensitivity to romiplostim N01 or excipients (cellulose-lactose, L-HPC, magnesium stearate, film coating).\n4. Refractory cytopenias:\n\n   * Hemoglobin \\\u003C50 g\u002FL despite RBC\u002FEPO;\n   * ANC \\\u003C1.0×10⁹\u002FL despite G-CSF.\n5. Pelvic\u002Fspinal\u002Flarge-field radiotherapy within 3 months.\n6. Arterial\u002Fvenous thrombosis within 3 months.\n7. Severe cardiovascular disease (NYHA Class III-IV, arrhythmia with thromboembolic risk, post-CABG\u002Fstent) within 6 months.\n8. Use of rhTPO, rhIL-11, or TPO-RAs (eltrombopag\u002Favatrombopag\u002Fhetrombopag) within 2 weeks.\n9. Investigator-assessed risks compromising safety\u002Fefficacy evaluation.","ALL","6 Years","24 Years",{"count":59,"type":60},50,"ESTIMATED","INTERVENTIONAL",[63],"PHASE2","The goal of this clinical trial is to evaluate the efficacy and safety of romiplostim N01 in treating chemotherapy-induced thrombocytopenia (CIT) in children and adolescents\u002Fyoung adults (CAYA; aged 6-24 years) with hematologic malignancies or solid tumors. The main questions it aims to answer are:\n\n* What proportion of participants achieve platelet count recovery (≥100×10⁹\u002FL or an increase of ≥30×10⁹\u002FL from baseline) within 3 weeks of romiplostim N01 treatment?\n* What is the safety profile of romiplostim N01 in this population, including the incidence and severity of adverse events (especially bleeding and thrombosis)? This is a single-arm study (no comparison group). Researchers will assess the outcomes against predefined efficacy thresholds and historical data (e.g., a 60.7% response rate reported for another TPO-RA, hetrombopag).\n\nParticipants will:\n\n* Receive weekly subcutaneous injections of romiplostim N01 (starting dose: 2 µg\u002Fkg).\n* Have their romiplostim dose adjusted weekly based on platelet counts (increase by 1-2 µg\u002Fkg if platelets \\\u003C99×10⁹\u002FL, maximum dose 10 µg\u002Fkg, stop when target recovery is met).\n* Undergo frequent monitoring, including blood tests (especially platelet counts), vital signs, physical exams, and assessment for adverse events and bleeding throughout the treatment and follow-up period.",[66,67,68,69,70],"Solid Tumors","Hematological Tumor","Children","Adolescent","Chemotherapy Induced Thrombocytopenia","2026-05-06",{"date":73,"type":74},"2026-05-07","ACTUAL",{"date":76,"type":74},"2025-12-25",{"date":78,"type":60},"2026-09-01",{"name":5,"class":6},1]