[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"thrombocytopenia-neonatal-alloimmune\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:thrombocytopenia-neonatal-alloimmune":59},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100557052",false,"NCT06533098","A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)","Multicenter, Open-Label, Randomized Study of Nipocalimab or IVIG in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)","FREESIA-3","Inclusion Criteria:\n\n* Pregnant and an estimated gestational age (GA) from week 13\\* to 18 at visit 1\n\n  \\*Randomization for high-risk FNAIT participants to occur at GA Week 12\n* Has a history of greater than or equal to (\\>=) 1 prior pregnancy with FNAIT based on medical records including: a) neonatal platelet count less than (\\\u003C) 150\\*10\\^9\u002FLiter with no fetal\u002Fneonatal intracranial hemorrhage (ICH) or severe fetal\u002Fneonatal hemorrhage (standard-risk) OR b) fetus\u002Fneonate with ICH or severe hemorrhage in a fetus\u002Fneonate (high-risk)\n* Current pregnancy with presence of maternal anti-HPA-1a and\u002For anti-HPA-5b alloantibody and positive fetal HPA-1a and\u002For HPA-5b genotype as confirmed by cell-free fetal DNA in maternal blood\n* Health status considered stable by the investigator based on physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening\n* For maternal participant and neonate\u002Finfant, willing to forego participation in another clinical study of an investigational therapy until the last follow-up visit\n\nExclusion Criteria:\n\n* Currently pregnant with multiple gestations (twins or more)\n* History of severe preeclampsia in a previous pregnancy\n* History of myocardial infarction, unstable ischemic heart disease, or stroke\n* Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients, to IVIG or to prednisone\n* Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant","FEMALE","18 Years","45 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to assess the efficacy and safety of nipocalimab in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).",[27],"Thrombocytopenia, Neonatal Alloimmune","RECRUITING","2026-06-04",{"date":31,"type":32},"2026-06-05","ACTUAL",{"date":34,"type":32},"2025-02-10",{"date":36,"type":21},"2029-12-05",{"name":38,"class":39},"Janssen Research & Development, LLC","INDUSTRY",26,{"id":42,"slug":4,"hasResults":10,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":53,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":57,"locationsCount":58},"100550636","NCT06449651","A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)","Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies","FREESIA-1","Inclusion Criteria:\n\n* Pregnant and an estimated gestational age (GA; based on ultrasound dating) from Week 13 to 18 at randomization\n* Has a history of greater than or equal to (\\>=) 1 prior pregnancy with fetal and neonatal alloimmune thrombocytopenia (FNAIT) (including neonatal platelet count less than (\\\u003C) 150×10\\^9\u002FLiter) with none of them affected by fetal\u002Fneonatal intracranial hemorrhage (ICH) or severe hemorrhage based on medical records\n* Current pregnancy with presence of maternal anti- human platelet antigen (HPA)-1a alloantibody and positive fetal HPA-1a genotype as confirmed by cell-free fetal deoxyribonucleic acid (DNA) in maternal blood\n* Health status considered stable by the investigator based on physical examination, medical history, vital signs, 12-lead Electrocardiogram (ECG), and clinical laboratory tests performed at screening\n* For maternal participant and neonate\u002Finfant, willing to forego participation in another clinical study of an investigational therapy until the last follow-up visit\n\nExclusion Criteria:\n\n* Currently pregnant with multiple gestations (twins or more)\n* History of severe preeclampsia in a previous pregnancy\n* History of myocardial infarction, unstable ischemic heart disease, or stroke\n* Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients (refer to the Investigator Brochure (IB))\n* Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant",{"count":49,"type":21},39,[24],"The purpose of this study is to evaluate the effectiveness of nipocalimab compared with placebo in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).",[27],{"date":31,"type":32},{"date":55,"type":32},"2024-11-11",{"date":36,"type":21},{"name":38,"class":39},21,""]