Un estudio de nipocalimab o inmunoglobulina intravenosa (IGIV) en embarazos con riesgo de trombocitopenia aloinmune fetal y neonatal (FNAIT) (FREESIA-3)
Estudio multicéntrico, abierto y aleatorizado de nipocalimab o inmunoglobulina intravenosa (IGIV) en embarazos con riesgo de trombocitopenia aloinmune fetal y neonatal (FNAIT)
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).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Study Contact
- Número de teléfono: 844-434-4210
- Correo electrónico: Participate-In-This-Study1@its.jnj.com
Ubicaciones de estudio
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Berlin, Alemania, 10117
- Reclutamiento
- Charite Universitaetsmedizin Berlin
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Giessen, Alemania, 35392
- Reclutamiento
- Universitaetsklinikum Giessen und Marburg GmbH
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Hanover, Alemania, 30625
- Reclutamiento
- Medizinische Hochschule Hannover
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Jena, Alemania, 07747
- Reclutamiento
- Universitatsklinikum Jena
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Tübingen, Alemania, 72076
- Reclutamiento
- Universitaetsklinikum Tuebingen
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Graz, Austria, 8036
- Reclutamiento
- Medizinische Universitaet Graz
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Vienna, Austria, 1090
- Reclutamiento
- Medical University Vienna
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Leuven, Bélgica, 3000
- Reclutamiento
- Universitair Ziekenhuis Leuven
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Košice, Eslovaquia, 040 11
- Reclutamiento
- Univerzitna nemocnica L. Pasteura Kosice
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Nové Zámky, Eslovaquia, 940 34
- Reclutamiento
- Fakultna nemocnica s poliklinikou Nove Zamky
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Ljubljana, Eslovenia, 1000
- Reclutamiento
- Univerzitetni klinicni center Ljubljana
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- Reclutamiento
- The University of Alabama at Birmingham
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California
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Sacramento, California, Estados Unidos, 95817
- Reclutamiento
- UC Davis School of Medicine
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- Reclutamiento
- Childrens Hospital Colorado
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Florida
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Gainesville, Florida, Estados Unidos, 32611
- Reclutamiento
- University of Florida at Shands
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Illinois
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Park Ridge, Illinois, Estados Unidos, 60068
- Reclutamiento
- Advocate Children's Hospital
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Suspendido
- Riley Children s Hospital
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242
- Reclutamiento
- University of Iowa Hospital and Clinics
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Michigan
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Detroit, Michigan, Estados Unidos, 48201
- Reclutamiento
- Wayne State University
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New York
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Rochester, New York, Estados Unidos, 14642
- Reclutamiento
- University of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- Reclutamiento
- University of North Carolina at Chapel Hill
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45267
- Reclutamiento
- University of Cincinnati
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Reclutamiento
- Oregon Health And Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Reclutamiento
- Hospital of the University of Pennsylvania
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37232
- Reclutamiento
- Vanderbilt University Medical Center
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Texas
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Galveston, Texas, Estados Unidos, 77555
- Reclutamiento
- University of Texas Medical Branch
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Utah
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Salt Lake City, Utah, Estados Unidos, 84108
- Reclutamiento
- University of Utah
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Ramat Gan, Israel, 5262000
- Reclutamiento
- Sheba Medical Center
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Milan, Italia, 20122
- Reclutamiento
- Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
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Roma, Italia, 00168
- Reclutamiento
- Fondazione Policlinico Universitario A Gemelli IRCCS
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Leiden, Países Bajos, 2333 ZA
- Reclutamiento
- Leiden University Medical Center
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Lodz, Polonia, 93 338
- Reclutamiento
- Instytut Centrum Zdrowia Matki Polki
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Warsaw, Polonia, 01 211
- Reclutamiento
- Instytut Matki i Dziecka
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Warsaw, Polonia, 02 507
- Reclutamiento
- Panstwowy Instytut Medyczny MSWiA w Warszawie
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Birmingham, Reino Unido, B15 2TG
- Reclutamiento
- Birmingham Women's Hospital
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Liverpool, Reino Unido, L8 7SS
- Reclutamiento
- Liverpool Women's NHS Foundation Trust - Liverpool Women's Hospital
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London, Reino Unido, W12 0HS
- Reclutamiento
- Queen Charlotte's and Chelsea Hospital
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Oxford, Reino Unido, OX3 9DU
- Reclutamiento
- John Radcliffe Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
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Pregnant and an estimated gestational age (GA) from week 13* to 18 at visit 1
*Randomization for high-risk FNAIT participants to occur at GA Week 12
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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 (<) 150*10^9/Liter with no fetal/neonatal intracranial hemorrhage (ICH) or severe fetal/neonatal hemorrhage (standard-risk) OR b) fetus/neonate with ICH or severe hemorrhage in a fetus/neonate (high-risk)
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Current pregnancy with presence of maternal anti-HPA-1a and/or anti-HPA-5b alloantibody and positive fetal HPA-1a and/or HPA-5b genotype as confirmed by cell-free fetal DNA in maternal blood
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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
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For maternal participant and neonate/infant, willing to forego participation in another clinical study of an investigational therapy until the last follow-up visit
Exclusion Criteria:
- Currently pregnant with multiple gestations (twins or more)
- History of severe preeclampsia in a previous pregnancy
- History of myocardial infarction, unstable ischemic heart disease, or stroke
- Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients, to IVIG or to prednisone that would preclude treatment
- Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Arm 1: Nipocalimab
Maternal participants with alloantibodies against HPA-1a and/or HPA-5b will be randomized to receive nipocalimab starting at gestational age (GA) week 13 to 18 until before delivery. |
Nipocalimab will be administered intravenously.
Otros nombres:
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Experimental: Arm 2: Intravenous Immunoglobins (IVIG)
Maternal participants with alloantibodies against HPA-1a and/or 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. |
IVIG will be administered intravenously. Prednisone will be administered orally. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L
Periodo de tiempo: Up to 1 Week post birth
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Outcome of fetus/neonate death or adjudicated severe bleeding up to the first week post birth or platelet count <30*10^9/L will be reported. |
Up to 1 Week post birth
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Platelet Count at Birth in a Neonate
Periodo de tiempo: At birth
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Platelet count at birth in a neonate will be reported. |
At birth
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Neonate/Fetus with Outcome of Death
Periodo de tiempo: Up to 1 Week post birth
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Fetus/neonate with outcome of death will be reported. |
Up to 1 Week post birth
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Neonate with Platelet Count at Birth <10*10^9/L
Periodo de tiempo: At birth
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Platelet count at birth <10*10^9/L in a neonate will be reported. |
At birth
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Neonate with Platelet Count at Birth <30*10^9/L
Periodo de tiempo: At birth
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Platelet count at birth <30*10^9/L in a neonate will be reported. |
At birth
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Neonate with Platelet Count at Birth <50*10^9/L
Periodo de tiempo: At birth
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Platelet count at birth <50*10^9/L in a neonate will be reported. |
At birth
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Neonate with Platelet Count at Birth <150*10^9/L
Periodo de tiempo: At birth
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Platelet count at birth <150*10^9/L in a neonate will be reported. |
At birth
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Nadir Platelet Count in a Neonate
Periodo de tiempo: Up to 1 Week post birth
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Nadir platelet count in a neonate will be reported. |
Up to 1 Week post birth
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Neonate Requiring Platelet Transfusion
Periodo de tiempo: Up to 1 Week post birth
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Neonate who require at least one platelet transfusion will be reported. |
Up to 1 Week post birth
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Number of Platelet Transfusions in Neonate
Periodo de tiempo: Up to 1 Week post birth
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Number of platelet transfusions per neonate will be reported. |
Up to 1 Week post birth
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Number of Donor Exposures for Platelet Transfusions in Neonate
Periodo de tiempo: Up to 1 Week post birth
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Number of donor exposures for a neonate who received at least one platelet transfusion will be reported. |
Up to 1 Week post birth
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Neonate/Fetus With Adjudicated Bleeding
Periodo de tiempo: Up to 1 Week post birth
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Neonate/Fetus with adjudicated bleeding will be reported. |
Up to 1 Week post birth
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Neonate Requiring Postnatal Intravenous Immunoglobulin (IVIG) for the Treatment of Thrombocytopenia
Periodo de tiempo: Up to 1 Week post birth
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Neonate requiring IVIG for the treatment of thrombocytopenia will be reported. |
Up to 1 Week post birth
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Maternal Participant with Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE) and Adverse Event of Special Interest (AESI)
Periodo de tiempo: Up to Week 24
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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
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Maternal Participant with TEAE Leading to Discontinuation of Study Intervention
Periodo de tiempo: Up to Week 24
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Maternal participant with TEAE leading to discontinuation of study intervention will be reported. |
Up to Week 24
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Neonate/Infant With TEAE, SAE and AESI
Periodo de tiempo: From Day of birth to Week 104
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Neonate/infant 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
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Fetus/Neonate with a TEAE of Bleeding
Periodo de tiempo: From Day of birth to Week 104
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Fetus/Neonate with a TEAE of bleeding will be reported. |
From Day of birth to Week 104
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Neonate with a TEAE of Infection
Periodo de tiempo: From Day of birth to Week 104
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Neonate with a TEAE of infection will be reported. |
From Day of birth to Week 104
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Bayley Scales Assessment for Infant Development
Periodo de tiempo: At Week 52 and Week 104
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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
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Maternal Participants with Incidence of Antibodies to Nipocalimab
Periodo de tiempo: Up to Week 4
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Incidence of antibodies to nipocalimab including neutralizing antibodies in maternal serum during pregnancy and postpartum will be reported. |
Up to Week 4
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Citopenia
- Infantil, Recién Nacido, Enfermedades
- Enfermedades hematológicas
- Trastornos de las plaquetas sanguíneas
- Trombocitopenia
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Enfermedades hemic y linfáticas
- Trombocitopenia Neonatal Aloinmune
- Aminoácidos, péptidos y proteínas
- Proteínas
- Compuestos policíclicos
- Anticuerpos
- Inmunoglobulinas
- Inmunoproteínas
- Proteínas de la sangre
- Globulinas séricas
- Globulinas
- Espierra
- Embarazos
- Esteroides
- Compuestos de anillo fusionado
- Madreadiediols
- Isotipos de inmunoglobulina
- Inmunoglobulina G
- Prednisona
- Inmunoglobulinas Intravenosas
Otros números de identificación del estudio
- 80202135FNAIT3003
- 2023-509434-19-00 (Identificador de registro: EUCT number)
- 2023 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .