[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550636":3},{"organization":4,"outcomesModule":7,"designInfo":94,"detailedDescription":93,"studyPopulation":93,"armGroups":103,"interventions":116,"overallOfficials":127,"centralContacts":131,"locations":137,"responsibleParty":354,"collaborators":93,"id":356,"slug":357,"hasResults":358,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":362,"eligibilityCriteria":363,"healthyVolunteers":358,"sex":364,"minAge":365,"maxAge":366,"enrollmentInfo":367,"targetDuration":93,"studyType":370,"phases":371,"briefSummary":373,"conditions":374,"keywords":93,"overallStatus":140,"whyStopped":93,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":385},{"fullName":5,"class":6},"Janssen Research & Development, LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":93},[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",[14,18,22,25,28,31,34,37,41,44,47,50,53,56,60,63,66,70,73,76,79,82,85,89],{"measure":15,"description":16,"timeFrame":17},"Neonate\u002FFetus With Adjudicated Bleeding","Neonate\u002Ffetus With adjudicated bleeding will be reported.","Up to 1 Week post birth",{"measure":19,"description":20,"timeFrame":21},"Platelet Count at Birth in a Neonate","Platelet count at birth in a neonate will be reported.","At birth",{"measure":23,"description":24,"timeFrame":17},"Neonate\u002FFetus with Outcome of Death","Fetus\u002Fneonate with outcome of death will be reported.",{"measure":26,"description":27,"timeFrame":21},"Platelet Count at Birth \u003C10×10^9\u002FL in a Neonate","Platelet count at birth \\\u003C10×10\\^9\u002FL in a neonate will be reported.",{"measure":29,"description":30,"timeFrame":21},"Platelet Count at Birth \u003C30×10^9\u002F L In a Neonate","Platelet count at birth \\\u003C30×10\\^9\u002FL in a neonate will be reported.",{"measure":32,"description":33,"timeFrame":21},"Platelet Count at Birth \u003C50×10^9\u002FL In a Neonate","Platelet count at birth \\\u003C50×10\\^9\u002FL in a neonate will be reported.",{"measure":35,"description":36,"timeFrame":21},"Platelet Count at Birth \u003C150×10^9\u002FL In a Neonate","Platelet count at birth \\\u003C150×10\\^9\u002FL in a neonate will be reported.",{"measure":38,"description":39,"timeFrame":40},"Nadir Platelet Count of a Neonate Over the First Week Post Birth","Nadir platelet count in a neonate will be reported.","Upto 1 Week post birth",{"measure":42,"description":43,"timeFrame":17},"Neonate\u002FFetus Requiring Platelet Transfusion(s)","Neonate(s) who require at least one platelet transfusion(s) will be reported.",{"measure":45,"description":46,"timeFrame":17},"Number of Platelet Transfusion(s) in Neonate\u002FFetus","Number of Platelet transfusion(s) per neonate will be reported.",{"measure":48,"description":49,"timeFrame":17},"Number of Donor Exposures for Platelet Transfusion(s) in Neonate\u002FFetus","Number of donor exposures for neonates who received platelet transfusion(s) will be reported.",{"measure":51,"description":52,"timeFrame":12},"Neonate\u002FFetus With Adjudicated Severe Bleeding","Neonate\u002FFetus With adjudicated severe bleeding will be reported.",{"measure":54,"description":55,"timeFrame":17},"Neonates With Postnatal Intravenous Immunoglobulin (IVIG) for The Treatment of Thrombocytopenia","Neonates with IVIG for the treatment of thrombocytopenia will be reported.",{"measure":57,"description":58,"timeFrame":59},"Maternal Participants With Treatment-Emergent Adverse Event (TEAE)","Maternal participants with a TEAE 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. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.","From randomization up to 24 weeks postpartum",{"measure":61,"description":62,"timeFrame":59},"Maternal Participants With Serious Adverse Event (SAE)","Maternal participants with SAE 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. SAE is any untoward medical occurrence that at any dose that results in death, is life-threatening, requires inpatient hospitalization\u002Fprolongation of existing hospitalization, results in persistent or significant disability\u002Fincapacity, is a congenital anomaly\u002Fbirth defect and is medically important.",{"measure":64,"description":65,"timeFrame":59},"Maternal Participants With Adverse Event of Special Interest (AESI)","Maternal participants with an 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. AESIs are considered as infections that are severe, hypoalbuminemia, deep vein thrombosis and\u002For pulmonary embolism, and clinically significant bleeding.",{"measure":67,"description":68,"timeFrame":69},"Maternal Participants with TEAE Leading to Discontinuation of Study Intervention","Maternal participants with TEAE leading to discontinuation of study intervention will be reported.","Up to Week 104",{"measure":71,"description":72,"timeFrame":69},"Neonate\u002FInfant with TEAE","Neonatal\u002Finfant participants with a TEAE 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. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.",{"measure":74,"description":75,"timeFrame":69},"Neonate\u002FInfant with SAE","Neonatal\u002Finfant participants with SAE 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. An SAE is any untoward medical occurrence that at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability\u002Fincapacity, is a congenital anomaly\u002Fbirth defect and is medically Important.",{"measure":77,"description":78,"timeFrame":69},"Neonate\u002FInfant with AESI","Neonatal\u002Finfant participants with 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. AESIs are considered as: In infants- clinically significant mortalities in fetus\u002Fneonates due to maternal infections, and hypogammaglobulinemia.",{"measure":80,"description":81,"timeFrame":69},"Fetus\u002FNeonate With TEAE of Bleeding","Fetus\u002FNeonate with TEAE of Bleeding 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. Treatment-emergent AEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.",{"measure":83,"description":84,"timeFrame":69},"Neonate With TEAE of Infection","Neonate with TEAE of Infection 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. Treatment-emergent AEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.",{"measure":86,"description":87,"timeFrame":88},"Infant Development as Measured by Bayley Scales at Week 52 and Week 104","The Bayley Scales of Infant and Toddler Development include a set of individually administered developmental scales designed to measure current developmental functioning in infants and toddlers up to 42 months of age in the areas of cognition, language, motor skills, social-emotional, and adaptive behavior, with age adjusted for prematurity. The cognition, language, 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.","At Week 52 and 104",{"measure":90,"description":91,"timeFrame":92},"Maternal Participants With Antibodies to Nipocalimab Including Neutralizing Antibodies in Maternal Serum During Pregnancy and Postpartum","Maternal participants with antibodies to nipocalimab including neutralizing antibodies in maternal serum during pregnancy and postpartum will be reported.","Up to Week 24",null,{"allocation":95,"interventionModel":96,"interventionModelDescription":93,"primaryPurpose":97,"observationalModel":93,"timePerspective":93,"maskingInfo":98},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":99,"maskingDescription":93,"whoMasked":100},"DOUBLE",[101,102],"PARTICIPANT","INVESTIGATOR",[104,110],{"label":105,"type":106,"description":107,"interventionNames":108},"Nipocalimab","ACTIVE_COMPARATOR","Maternal participants will receive nipocalimab Intravenously (IV).",[109],"Drug: Nipocalimab",{"label":111,"type":112,"description":113,"interventionNames":114},"Placebo","PLACEBO_COMPARATOR","Maternal participants will receive placebo IV.",[115],"Drug: Placebo",[117,124],{"type":118,"name":105,"description":119,"armGroupLabels":120,"otherNames":121},"DRUG","Nipocalimab will be administered intravenously.",[105],[122,123],"JNJ-80202135","JNJ-86507083",{"type":118,"name":111,"description":125,"armGroupLabels":126,"otherNames":93},"Placebo will be administered intravenously.",[111],[128],{"name":129,"affiliation":5,"role":130},"Janssen Research & Development, LLC Clinical Trial","STUDY_DIRECTOR",[132],{"name":133,"role":134,"phone":135,"phoneExt":93,"email":136},"Study Contact","CONTACT","844-434-4210","Participate-In-This-Study1@its.jnj.com",[138,151,162,171,180,191,200,211,222,233,242,253,262,271,280,291,300,309,320,332,343],{"facility":139,"status":140,"city":141,"state":93,"zip":142,"country":143,"countryCode":144,"cosmosGeoPoint":145,"geoPoint":150,"contacts":93},"Universitair Ziekenhuis Leuven","RECRUITING","Leuven","3000","Belgium","BE",{"type":146,"coordinates":147},"Point",[148,149],4.70093,50.87959,{"lat":149,"lon":148},{"facility":152,"status":140,"city":153,"state":93,"zip":154,"country":155,"countryCode":156,"cosmosGeoPoint":157,"geoPoint":161,"contacts":93},"Instituto de Medicina Integral Professor Fernando Figueira","Recife","50070-902","Brazil","BR",{"type":146,"coordinates":158},[159,160],-34.88111,-8.05389,{"lat":160,"lon":159},{"facility":163,"status":140,"city":164,"state":93,"zip":165,"country":155,"countryCode":156,"cosmosGeoPoint":166,"geoPoint":170,"contacts":93},"IDOR - Regional Rio de Janeiro","Rio de Janeiro","22281 100",{"type":146,"coordinates":167},[168,169],-43.18223,-22.90642,{"lat":169,"lon":168},{"facility":172,"status":140,"city":173,"state":93,"zip":174,"country":155,"countryCode":156,"cosmosGeoPoint":175,"geoPoint":179,"contacts":93},"Hospital Das Clinicas Da Faculdade De Medicina Da USP","São Paulo","05403 000",{"type":146,"coordinates":176},[177,178],-46.63611,-23.5475,{"lat":178,"lon":177},{"facility":181,"status":140,"city":182,"state":93,"zip":183,"country":184,"countryCode":185,"cosmosGeoPoint":186,"geoPoint":190,"contacts":93},"CHRU Lille","Lille","59000","France","FR",{"type":146,"coordinates":187},[188,189],3.05512,50.63391,{"lat":189,"lon":188},{"facility":192,"status":140,"city":193,"state":93,"zip":194,"country":184,"countryCode":185,"cosmosGeoPoint":195,"geoPoint":199,"contacts":93},"Hopital trousseau- APHP","Paris","75012",{"type":146,"coordinates":196},[197,198],2.3488,48.85341,{"lat":198,"lon":197},{"facility":201,"status":140,"city":202,"state":93,"zip":203,"country":204,"countryCode":205,"cosmosGeoPoint":206,"geoPoint":210,"contacts":93},"Semmelweis Egyetem","Budapest","1082","Hungary","HU",{"type":146,"coordinates":207},[208,209],19.04045,47.49835,{"lat":209,"lon":208},{"facility":212,"status":140,"city":213,"state":93,"zip":214,"country":215,"countryCode":216,"cosmosGeoPoint":217,"geoPoint":221,"contacts":93},"Sheba Medical Center","Ramat Gan","5262000","Israel","IL",{"type":146,"coordinates":218},[219,220],34.81065,32.08227,{"lat":220,"lon":219},{"facility":223,"status":140,"city":224,"state":93,"zip":225,"country":226,"countryCode":227,"cosmosGeoPoint":228,"geoPoint":232,"contacts":93},"Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico","Milan","20122","Italy","IT",{"type":146,"coordinates":229},[230,231],12.59836,42.78235,{"lat":231,"lon":230},{"facility":234,"status":140,"city":235,"state":93,"zip":236,"country":226,"countryCode":227,"cosmosGeoPoint":237,"geoPoint":241,"contacts":93},"Fondazione Policlinico Universitario A Gemelli IRCCS","Rome","00168",{"type":146,"coordinates":238},[239,240],12.51133,41.89193,{"lat":240,"lon":239},{"facility":243,"status":140,"city":244,"state":93,"zip":245,"country":246,"countryCode":247,"cosmosGeoPoint":248,"geoPoint":252,"contacts":93},"Haukeland University Hospital","Bergen","5009","Norway","NO",{"type":146,"coordinates":249},[250,251],5.32415,60.39299,{"lat":251,"lon":250},{"facility":254,"status":140,"city":255,"state":93,"zip":256,"country":246,"countryCode":247,"cosmosGeoPoint":257,"geoPoint":261,"contacts":93},"Oslo University Hospital HF Ulleval sykehus","Oslo","0455",{"type":146,"coordinates":258},[259,260],10.74609,59.91273,{"lat":260,"lon":259},{"facility":263,"status":140,"city":264,"state":93,"zip":265,"country":246,"countryCode":247,"cosmosGeoPoint":266,"geoPoint":270,"contacts":93},"Universitetssykehuset Nord-Norge HF","Tromsø","9019",{"type":146,"coordinates":267},[268,269],18.95508,69.6489,{"lat":269,"lon":268},{"facility":272,"status":140,"city":273,"state":93,"zip":274,"country":246,"countryCode":247,"cosmosGeoPoint":275,"geoPoint":279,"contacts":93},"St. Olavs Hospital","Trondheim","7030",{"type":146,"coordinates":276},[277,278],10.39506,63.43049,{"lat":278,"lon":277},{"facility":281,"status":140,"city":282,"state":93,"zip":283,"country":284,"countryCode":285,"cosmosGeoPoint":286,"geoPoint":290,"contacts":93},"Univerzitna nemocnica L. Pasteura Kosice","Košice","04190","Slovakia","SK",{"type":146,"coordinates":287},[288,289],21.25802,48.71441,{"lat":289,"lon":288},{"facility":292,"status":140,"city":293,"state":93,"zip":294,"country":284,"countryCode":285,"cosmosGeoPoint":295,"geoPoint":299,"contacts":93},"Univerzitná nemocnica Martin","Martin","036 01",{"type":146,"coordinates":296},[297,298],18.92399,49.06651,{"lat":298,"lon":297},{"facility":301,"status":140,"city":302,"state":93,"zip":303,"country":284,"countryCode":285,"cosmosGeoPoint":304,"geoPoint":308,"contacts":93},"Fakultna nemocnica s poliklinikou Nove Zamky","Nové Zámky","940 34",{"type":146,"coordinates":305},[306,307],18.16195,47.98544,{"lat":307,"lon":306},{"facility":310,"status":140,"city":311,"state":93,"zip":312,"country":313,"countryCode":314,"cosmosGeoPoint":315,"geoPoint":319,"contacts":93},"Univerzitetni klinicni center Ljubljana","Ljubljana","1000","Slovenia","SI",{"type":146,"coordinates":316},[317,318],14.50513,46.05108,{"lat":318,"lon":317},{"facility":321,"status":322,"city":323,"state":93,"zip":324,"country":325,"countryCode":326,"cosmosGeoPoint":327,"geoPoint":331,"contacts":93},"Hosp. Virgen Del Rocio","COMPLETED","Seville","41013","Spain","ES",{"type":146,"coordinates":328},[329,330],-5.97317,37.38283,{"lat":330,"lon":329},{"facility":333,"status":140,"city":334,"state":93,"zip":335,"country":336,"countryCode":337,"cosmosGeoPoint":338,"geoPoint":342,"contacts":93},"Karolinska Universitetssjukhuset Huddinge","Stockholm","SE-141 86","Sweden","SE",{"type":146,"coordinates":339},[340,341],18.06871,59.32938,{"lat":341,"lon":340},{"facility":344,"status":140,"city":345,"state":93,"zip":346,"country":347,"countryCode":348,"cosmosGeoPoint":349,"geoPoint":353,"contacts":93},"Centre Hospitalier Universitaire Vaudois CHUV","Lausanne","1011","Switzerland","CH",{"type":146,"coordinates":350},[351,352],6.63282,46.516,{"lat":352,"lon":351},{"type":355,"investigatorFullName":93,"investigatorTitle":93,"investigatorAffiliation":93,"oldNameTitle":93,"oldOrganization":93},"SPONSOR","100550636","phase-3-a-study-of-nipocalimab-in-reducing-the-risk-of-fetal-and-neonatal-alloimmune-thrombocytopenia-fnait-100550636",false,"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 a clinical review of the 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","FEMALE","18 Years","45 Years",{"count":368,"type":369},39,"ESTIMATED","INTERVENTIONAL",[372],"PHASE3","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).",[375],"Thrombocytopenia, Neonatal Alloimmune","2026-08-27",{"date":378,"type":379},"2026-08-28","ACTUAL",{"date":381,"type":379},"2024-11-11",{"date":383,"type":369},"2029-12-05",{"name":5,"class":6},21]