[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622539":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":51,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":11,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":11,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":78,"whyStopped":11,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Lanzhou University Second Hospital","OTHER",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Topefilgrastim 0.5mg Group","EXPERIMENTAL",null,[13],"Drug: Topefilgrastim Injection",{"label":15,"type":10,"description":11,"interventionNames":16},"Topefilgrastim 1mg Group",[13],{"label":18,"type":19,"description":11,"interventionNames":11},"Control Group","NO_INTERVENTION",[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"DRUG","Topefilgrastim Injection","Subjects will receive subcutaneous injection of 0.5 mg Topefilgrastim starting from Week 1 Day 1 (W1D1), with a frequency of once every two weeks, for at least 8 consecutive weeks.",[9],{"type":22,"name":23,"description":27,"armGroupLabels":28,"otherNames":11},"Subjects will receive subcutaneous injection of 1 mg Topefilgrastim starting from Week 1 Day 1 (W1D1), with a frequency of once every two weeks, for at least 8 consecutive weeks.",[15],[30],{"name":31,"affiliation":5,"role":32},"Fang Wang","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":11,"email":37},"CONTACT","13919302888","ery_fwang@lzu.edu.cn",[39],{"facility":5,"status":11,"city":40,"state":11,"zip":11,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Lanzhou","China","CN",{"type":44,"coordinates":45},"Point",[46,47],103.83987,36.05701,{"lat":47,"lon":46},[50],{"name":31,"role":35,"phone":11,"phoneExt":11,"email":11},{"type":52,"investigatorFullName":31,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Chief physician",[55],{"name":56,"class":57},"Xiamen Amoytop Biotech Co., Ltd.","INDUSTRY","100622539","topefilgrastim-injection-in-the-treatment-of-high-risk-pregnant-patients-with-preeclampsia-100622539",false,"NCT07384936","Topefilgrastim Injection in the Treatment of High-Risk Pregnant Patients With Preeclampsia","A Prospective, Controlled Study to Assess the Preliminary Efficacy and Safety of Topefilgrastim Injection in High-Risk Pregnant Patients With Preeclampsia.","Inclusion Criteria:\n\n* Voluntarily participate in the study, be able to understand, and sign the informed consent form.\n* Aged 18 to 45 years (inclusive) at the time of signing the informed consent form.\n* Assessed as high-risk for preeclampsia at gestational weeks 11-13, defined as either:\n\nA risk value of ≥1\u002F100 based on the simplified Fetal Medicine Foundation (FMF) model, OR A high-risk result from serum biomarker screening (sFlt-1, PLGF, sFlt-1\u002FPLGF ratio). (See Appendix for details)\n\n* Gestational weeks 11-13 at enrollment.\n* Singleton intrauterine pregnancy (confirmed by transvaginal or transabdominal ultrasound).\n\nExclusion Criteria:\n\n* History of psychiatric disorder not adequately controlled by medication.\n* Unexplained vaginal bleeding at screening.\n* Known uterine malformation.\n* Evidence of positive serology for HIV, HBV (HBsAg positive), HCV (anti-HCV antibody positive), or syphilis.\n* Known proliferative retinopathy.\n* Presence of severe organic disease or any other condition that, in the judgment of the investigator, makes the subject unsuitable for study participation.\n* Planned or current use of medications with potential drug-drug interactions with human granulocyte colony-stimulating factor (G-CSF) analogs, such as lithium.\n* Known allergy to rhG-CSF products or their components, or allergy to recombinant human proteins\u002Fpeptides derived from E. coli.","FEMALE","18 Years","45 Years",{"count":69,"type":70},100,"ESTIMATED","INTERVENTIONAL",[73],"NA","This study is an open-label, prospective investigation designed to enroll 100 high-risk pregnant subjects with preeclampsia (PE). Participants will be allocated in a 2:2:1 ratio to one of three groups: the Topefilgrastim 0.5mg\u002Fbiweekly group, the Topefilgrastim 1mg\u002Fbiweekly group, or the control group, based on investigator judgment and patient preference. The overall study consists of three parts: a screening period, a treatment period, and a follow-up period.",[76],"Preeclampsia",[76,23],"NOT_YET_RECRUITING","2026-01-26",{"date":81,"type":82},"2026-02-03","ACTUAL",{"date":84,"type":70},"2026-01-31",{"date":86,"type":70},"2027-12",{"name":31,"class":6},1]