[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557052":3},{"organization":4,"outcomesModule":7,"designInfo":77,"detailedDescription":76,"studyPopulation":76,"armGroups":83,"interventions":96,"overallOfficials":114,"centralContacts":118,"locations":124,"responsibleParty":403,"collaborators":76,"id":405,"slug":406,"hasResults":407,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":407,"sex":413,"minAge":414,"maxAge":415,"enrollmentInfo":416,"targetDuration":76,"studyType":419,"phases":420,"briefSummary":422,"conditions":423,"keywords":76,"overallStatus":127,"whyStopped":76,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":434},{"fullName":5,"class":6},"Janssen Research & Development, LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":76},[9],{"measure":10,"description":11,"timeFrame":12},"Fetus\u002FNeonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (\u003C) 30*10^9\u002FL","Outcome of fetus\u002Fneonate death or adjudicated severe bleeding up to the first week post birth or platelet count \\\u003C30\\*10\\^9\u002FL will be reported.","Up to 1 Week post birth",[14,18,21,24,27,30,33,36,39,42,45,48,51,55,58,62,65,68,72],{"measure":15,"description":16,"timeFrame":17},"Platelet Count at Birth in a Neonate","Platelet count at birth in a neonate will be reported.","At birth",{"measure":19,"description":20,"timeFrame":12},"Neonate\u002FFetus with Outcome of Death","Fetus\u002Fneonate with outcome of death will be reported.",{"measure":22,"description":23,"timeFrame":17},"Neonate with Platelet Count at Birth \u003C10*10^9\u002FL","Platelet count at birth \\\u003C10\\*10\\^9\u002FL in a neonate will be reported.",{"measure":25,"description":26,"timeFrame":17},"Neonate with Platelet Count at Birth \u003C30*10^9\u002FL","Platelet count at birth \\\u003C30\\*10\\^9\u002FL in a neonate will be reported.",{"measure":28,"description":29,"timeFrame":17},"Neonate with Platelet Count at Birth \u003C50*10^9\u002FL","Platelet count at birth \\\u003C50\\*10\\^9\u002FL in a neonate will be reported.",{"measure":31,"description":32,"timeFrame":17},"Neonate with Platelet Count at Birth \u003C150*10^9\u002FL","Platelet count at birth \\\u003C150\\*10\\^9\u002FL in a neonate will be reported.",{"measure":34,"description":35,"timeFrame":12},"Nadir Platelet Count in a Neonate","Nadir platelet count in a neonate will be reported.",{"measure":37,"description":38,"timeFrame":12},"Neonate Requiring Platelet Transfusion","Neonate who require at least one platelet transfusion will be reported.",{"measure":40,"description":41,"timeFrame":12},"Number of Platelet Transfusions in Neonate","Number of platelet transfusions per neonate will be reported.",{"measure":43,"description":44,"timeFrame":12},"Number of Donor Exposures for Platelet Transfusions in Neonate","Number of donor exposures for a neonate who received at least one platelet transfusion will be reported.",{"measure":46,"description":47,"timeFrame":12},"Neonate\u002FFetus With Adjudicated Bleeding","Neonate\u002FFetus with adjudicated bleeding will be reported.",{"measure":49,"description":50,"timeFrame":12},"Neonate Requiring Postnatal Intravenous Immunoglobulin (IVIG) for the Treatment of Thrombocytopenia","Neonate requiring IVIG for the treatment of thrombocytopenia will be reported.",{"measure":52,"description":53,"timeFrame":54},"Maternal Participant with Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE) and Adverse Event of Special Interest (AESI)","Maternal participant with TEAE, SAE and AESI will be reported. An Adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study.","Up to Week 24",{"measure":56,"description":57,"timeFrame":54},"Maternal Participant with TEAE Leading to Discontinuation of Study Intervention","Maternal participant with TEAE leading to discontinuation of study intervention will be reported.",{"measure":59,"description":60,"timeFrame":61},"Neonate\u002FInfant With TEAE, SAE and AESI","Neonate\u002Finfant with TEAE, SAE and AESI will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study.","From Day of birth to Week 104",{"measure":63,"description":64,"timeFrame":61},"Fetus\u002FNeonate with a TEAE of Bleeding","Fetus\u002FNeonate with a TEAE of bleeding will be reported.",{"measure":66,"description":67,"timeFrame":61},"Neonate with a TEAE of Infection","Neonate with a TEAE of infection will be reported.",{"measure":69,"description":70,"timeFrame":71},"Bayley Scales Assessment for Infant Development","The Bayley Scales of infant development is considered the standard assessment of early child development and includes cognition, language, motor skills, social emotional, and adaptive behavior will be reported. The Bayley Scales are reference standards that measure infant and toddler development in five areas: cognition, language, motor skills, social-emotional and adaptive behavior. The cognition, language and motor skills scales are directly administered to the infant, while social-emotional, and adaptive behavior scales are caregiver questionnaires. The scores are standardized using norm reference samples with representative demographics and age adjusted for prematurity. Higher scores in the Bayley Scales indicate better outcomes.","At Week 52 and Week 104",{"measure":73,"description":74,"timeFrame":75},"Maternal Participants with Incidence of Antibodies to Nipocalimab","Incidence of antibodies to nipocalimab including neutralizing antibodies in maternal serum during pregnancy and postpartum will be reported.","Up to Week 4",null,{"allocation":78,"interventionModel":79,"interventionModelDescription":76,"primaryPurpose":80,"observationalModel":76,"timePerspective":76,"maskingInfo":81},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":82,"maskingDescription":76,"whoMasked":76},"NONE",[84,90],{"label":85,"type":86,"description":87,"interventionNames":88},"Arm 1: Nipocalimab","EXPERIMENTAL","Maternal participants with alloantibodies against HPA-1a and\u002For HPA-5b will be randomized to receive nipocalimab starting at gestational age (GA) week 13 to 18 until before delivery.",[89],"Drug: Nipocalimab",{"label":91,"type":86,"description":92,"interventionNames":93},"Arm 2: Intravenous Immunoglobins (IVIG)","Maternal participants with alloantibodies against HPA-1a and\u002For HPA-5b will be randomized to receive IVIG from GA week 12 for high-risk pregnancies or GA week 20 for standard-risk pregnancies. Additionally, prednisone will be added per study protocol. Participants will be gradually tapered off prednisone after delivery as per investigator judgement or maternal participant tolerance.",[94,95],"Drug: Intravenous immunoglobulins (IVIG)","Drug: Prednisone",[97,106,110],{"type":98,"name":99,"description":100,"armGroupLabels":101,"otherNames":102},"DRUG","Nipocalimab","Nipocalimab will be administered intravenously.",[85],[103,104,105],"JNJ-80202135","JNJ-86507083","M281",{"type":98,"name":107,"description":108,"armGroupLabels":109,"otherNames":76},"Intravenous immunoglobulins (IVIG)","IVIG will be administered intravenously.",[91],{"type":98,"name":111,"description":112,"armGroupLabels":113,"otherNames":76},"Prednisone","Prednisone will be administered orally.",[91],[115],{"name":116,"affiliation":5,"role":117},"Janssen Research & Development, LLC Clinical Trial","STUDY_DIRECTOR",[119],{"name":120,"role":121,"phone":122,"phoneExt":76,"email":123},"Study Contact","CONTACT","844-434-4210","Participate-In-This-Study1@its.jnj.com",[125,139,149,159,169,180,190,200,210,220,230,240,250,260,271,280,291,300,309,318,329,340,351,360,366,376,385,394],{"facility":126,"status":127,"city":128,"state":129,"zip":130,"country":131,"countryCode":132,"cosmosGeoPoint":133,"geoPoint":138,"contacts":76},"The University of Alabama at Birmingham","RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":134,"coordinates":135},"Point",[136,137],-86.80249,33.52066,{"lat":137,"lon":136},{"facility":140,"status":127,"city":141,"state":142,"zip":143,"country":131,"countryCode":132,"cosmosGeoPoint":144,"geoPoint":148,"contacts":76},"UC Davis School of Medicine","Sacramento","California","95817",{"type":134,"coordinates":145},[146,147],-121.4944,38.58157,{"lat":147,"lon":146},{"facility":150,"status":127,"city":151,"state":152,"zip":153,"country":131,"countryCode":132,"cosmosGeoPoint":154,"geoPoint":158,"contacts":76},"Childrens Hospital Colorado","Aurora","Colorado","80045",{"type":134,"coordinates":155},[156,157],-104.83192,39.72943,{"lat":157,"lon":156},{"facility":160,"status":127,"city":161,"state":162,"zip":163,"country":131,"countryCode":132,"cosmosGeoPoint":164,"geoPoint":168,"contacts":76},"Advocate Children's Hospital","Park Ridge","Illinois","60068",{"type":134,"coordinates":165},[166,167],-87.84062,42.01114,{"lat":167,"lon":166},{"facility":170,"status":171,"city":172,"state":173,"zip":174,"country":131,"countryCode":132,"cosmosGeoPoint":175,"geoPoint":179,"contacts":76},"Riley Children s Hospital","SUSPENDED","Indianapolis","Indiana","46202",{"type":134,"coordinates":176},[177,178],-86.15804,39.76838,{"lat":178,"lon":177},{"facility":181,"status":127,"city":182,"state":183,"zip":184,"country":131,"countryCode":132,"cosmosGeoPoint":185,"geoPoint":189,"contacts":76},"University of Iowa Hospital and Clinics","Iowa City","Iowa","52242",{"type":134,"coordinates":186},[187,188],-91.53017,41.66113,{"lat":188,"lon":187},{"facility":191,"status":127,"city":192,"state":193,"zip":194,"country":131,"countryCode":132,"cosmosGeoPoint":195,"geoPoint":199,"contacts":76},"University of Rochester Medical Center","Rochester","New York","14642",{"type":134,"coordinates":196},[197,198],-77.61556,43.15478,{"lat":198,"lon":197},{"facility":201,"status":127,"city":202,"state":203,"zip":204,"country":131,"countryCode":132,"cosmosGeoPoint":205,"geoPoint":209,"contacts":76},"University of North Carolina at Chapel Hill","Chapel Hill","North Carolina","27599",{"type":134,"coordinates":206},[207,208],-79.05584,35.9132,{"lat":208,"lon":207},{"facility":211,"status":127,"city":212,"state":213,"zip":214,"country":131,"countryCode":132,"cosmosGeoPoint":215,"geoPoint":219,"contacts":76},"University of Cincinnati","Cincinnati","Ohio","45267",{"type":134,"coordinates":216},[217,218],-84.51439,39.12711,{"lat":218,"lon":217},{"facility":221,"status":127,"city":222,"state":223,"zip":224,"country":131,"countryCode":132,"cosmosGeoPoint":225,"geoPoint":229,"contacts":76},"Oregon Health And Science University","Portland","Oregon","97239",{"type":134,"coordinates":226},[227,228],-122.67621,45.52345,{"lat":228,"lon":227},{"facility":231,"status":127,"city":232,"state":233,"zip":234,"country":131,"countryCode":132,"cosmosGeoPoint":235,"geoPoint":239,"contacts":76},"Hospital of the University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"type":134,"coordinates":236},[237,238],-75.16362,39.95238,{"lat":238,"lon":237},{"facility":241,"status":127,"city":242,"state":243,"zip":244,"country":131,"countryCode":132,"cosmosGeoPoint":245,"geoPoint":249,"contacts":76},"University of Texas Medical Branch","Galveston","Texas","77555",{"type":134,"coordinates":246},[247,248],-94.7977,29.30135,{"lat":248,"lon":247},{"facility":251,"status":127,"city":252,"state":253,"zip":254,"country":131,"countryCode":132,"cosmosGeoPoint":255,"geoPoint":259,"contacts":76},"University of Utah","Salt Lake City","Utah","84108",{"type":134,"coordinates":256},[257,258],-111.89105,40.76078,{"lat":258,"lon":257},{"facility":261,"status":127,"city":262,"state":76,"zip":263,"country":264,"countryCode":265,"cosmosGeoPoint":266,"geoPoint":270,"contacts":76},"Medizinische Universitaet Graz","Graz","8036","Austria","AT",{"type":134,"coordinates":267},[268,269],15.44197,47.06733,{"lat":269,"lon":268},{"facility":272,"status":127,"city":273,"state":76,"zip":274,"country":264,"countryCode":265,"cosmosGeoPoint":275,"geoPoint":279,"contacts":76},"Medical University Vienna","Vienna","1090",{"type":134,"coordinates":276},[277,278],16.37208,48.20849,{"lat":278,"lon":277},{"facility":281,"status":127,"city":282,"state":76,"zip":283,"country":284,"countryCode":285,"cosmosGeoPoint":286,"geoPoint":290,"contacts":76},"Universitaetsklinikum Giessen und Marburg GmbH","Giessen","35392","Germany","DE",{"type":134,"coordinates":287},[288,289],8.67554,50.58727,{"lat":289,"lon":288},{"facility":292,"status":127,"city":293,"state":76,"zip":294,"country":284,"countryCode":285,"cosmosGeoPoint":295,"geoPoint":299,"contacts":76},"Medizinische Hochschule Hannover","Hanover","30625",{"type":134,"coordinates":296},[297,298],9.73322,52.37052,{"lat":298,"lon":297},{"facility":301,"status":127,"city":302,"state":76,"zip":303,"country":284,"countryCode":285,"cosmosGeoPoint":304,"geoPoint":308,"contacts":76},"Universitatsklinikum Jena","Jena","07747",{"type":134,"coordinates":305},[306,307],11.5899,50.92878,{"lat":307,"lon":306},{"facility":310,"status":127,"city":311,"state":76,"zip":312,"country":284,"countryCode":285,"cosmosGeoPoint":313,"geoPoint":317,"contacts":76},"Universitaetsklinikum Tuebingen","Tübingen","72076",{"type":134,"coordinates":314},[315,316],9.05222,48.52266,{"lat":316,"lon":315},{"facility":319,"status":127,"city":320,"state":76,"zip":321,"country":322,"countryCode":323,"cosmosGeoPoint":324,"geoPoint":328,"contacts":76},"Sheba Medical Center","Ramat Gan","5262000","Israel","IL",{"type":134,"coordinates":325},[326,327],34.81065,32.08227,{"lat":327,"lon":326},{"facility":330,"status":127,"city":331,"state":76,"zip":332,"country":333,"countryCode":334,"cosmosGeoPoint":335,"geoPoint":339,"contacts":76},"Leiden University Medical Center","Leiden","2333 ZA","Netherlands","NL",{"type":134,"coordinates":336},[337,338],4.49306,52.15833,{"lat":338,"lon":337},{"facility":341,"status":127,"city":342,"state":76,"zip":343,"country":344,"countryCode":345,"cosmosGeoPoint":346,"geoPoint":350,"contacts":76},"Instytut Centrum Zdrowia Matki Polki","Lodz","93 338","Poland","PL",{"type":134,"coordinates":347},[348,349],19.47395,51.77058,{"lat":349,"lon":348},{"facility":352,"status":127,"city":353,"state":76,"zip":354,"country":344,"countryCode":345,"cosmosGeoPoint":355,"geoPoint":359,"contacts":76},"Instytut Matki i Dziecka","Warsaw","01 211",{"type":134,"coordinates":356},[357,358],21.01178,52.22977,{"lat":358,"lon":357},{"facility":361,"status":127,"city":353,"state":76,"zip":362,"country":344,"countryCode":345,"cosmosGeoPoint":363,"geoPoint":365,"contacts":76},"Panstwowy Instytut Medyczny MSWiA w Warszawie","02 507",{"type":134,"coordinates":364},[357,358],{"lat":358,"lon":357},{"facility":367,"status":127,"city":128,"state":76,"zip":368,"country":369,"countryCode":370,"cosmosGeoPoint":371,"geoPoint":375,"contacts":76},"Birmingham Women's Hospital","B15 2TG","United Kingdom","UK",{"type":134,"coordinates":372},[373,374],-1.89983,52.48142,{"lat":374,"lon":373},{"facility":377,"status":127,"city":378,"state":76,"zip":379,"country":369,"countryCode":370,"cosmosGeoPoint":380,"geoPoint":384,"contacts":76},"Liverpool Women's NHS Foundation Trust - Liverpool Women's Hospital","Liverpool","L8 7SS",{"type":134,"coordinates":381},[382,383],-2.97794,53.41058,{"lat":383,"lon":382},{"facility":386,"status":127,"city":387,"state":76,"zip":388,"country":369,"countryCode":370,"cosmosGeoPoint":389,"geoPoint":393,"contacts":76},"Queen Charlotte's and Chelsea Hospital","London","W12 0HS",{"type":134,"coordinates":390},[391,392],-0.12574,51.50853,{"lat":392,"lon":391},{"facility":395,"status":127,"city":396,"state":76,"zip":397,"country":369,"countryCode":370,"cosmosGeoPoint":398,"geoPoint":402,"contacts":76},"John Radcliffe Hospital","Oxford","OX3 9DU",{"type":134,"coordinates":399},[400,401],-1.25596,51.75222,{"lat":401,"lon":400},{"type":404,"investigatorFullName":76,"investigatorTitle":76,"investigatorAffiliation":76,"oldNameTitle":76,"oldOrganization":76},"SPONSOR","100557052","phase-3-a-study-of-nipocalimab-or-intravenous-immunoglobulin-ivig-in-pregnancies-at-risk-of-fetal-and-neonatal-alloimmune-thrombocytopenia-fnait-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":417,"type":418},50,"ESTIMATED","INTERVENTIONAL",[421],"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).",[424],"Thrombocytopenia, Neonatal Alloimmune","2026-08-27",{"date":427,"type":428},"2026-08-28","ACTUAL",{"date":430,"type":428},"2025-02-10",{"date":432,"type":418},"2029-12-11",{"name":5,"class":6},28]