Uno studio su Nipocalimab o immunoglobulina endovenosa (IVIG) nelle gravidanze a rischio di trombocitopenia alloimmune fetale e neonatale (FNAIT) (FREESIA-3)
Studio multicentrico, in aperto, randomizzato su nipocalimab o immunoglobulina endovenosa (IVIG) nelle gravidanze a rischio di trombocitopenia alloimmune fetale e neonatale (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).
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 3
Contatti e Sedi
Contatto studio
- Nome: Study Contact
- Numero di telefono: 844-434-4210
- Email: Participate-In-This-Study1@its.jnj.com
Luoghi di studio
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Graz, Austria, 8036
- Reclutamento
- Medizinische Universitaet Graz
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Vienna, Austria, 1090
- Reclutamento
- Medical University Vienna
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Leuven, Belgio, 3000
- Reclutamento
- Universitair Ziekenhuis Leuven
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Berlin, Germania, 10117
- Reclutamento
- Charite Universitaetsmedizin Berlin
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Giessen, Germania, 35392
- Reclutamento
- Universitaetsklinikum Giessen und Marburg GmbH
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Hanover, Germania, 30625
- Reclutamento
- Medizinische Hochschule Hannover
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Jena, Germania, 07747
- Reclutamento
- Universitatsklinikum Jena
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Tübingen, Germania, 72076
- Reclutamento
- Universitaetsklinikum Tuebingen
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Ramat Gan, Israele, 5262000
- Reclutamento
- Sheba Medical Center
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Milan, Italia, 20122
- Reclutamento
- Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
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Roma, Italia, 00168
- Reclutamento
- Fondazione Policlinico Universitario A Gemelli IRCCS
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Leiden, Olanda, 2333 ZA
- Reclutamento
- Leiden University Medical Center
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Lodz, Polonia, 93 338
- Reclutamento
- Instytut Centrum Zdrowia Matki Polki
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Warsaw, Polonia, 01 211
- Reclutamento
- Instytut Matki i Dziecka
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Warsaw, Polonia, 02 507
- Reclutamento
- Panstwowy Instytut Medyczny MSWiA w Warszawie
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Birmingham, Regno Unito, B15 2TG
- Reclutamento
- Birmingham Women's Hospital
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Liverpool, Regno Unito, L8 7SS
- Reclutamento
- Liverpool Women's NHS Foundation Trust - Liverpool Women's Hospital
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London, Regno Unito, W12 0HS
- Reclutamento
- Queen Charlotte's and Chelsea Hospital
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Oxford, Regno Unito, OX3 9DU
- Reclutamento
- John Radcliffe Hospital
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Košice, Slovacchia, 040 11
- Reclutamento
- Univerzitna nemocnica L. Pasteura Kosice
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Nové Zámky, Slovacchia, 940 34
- Reclutamento
- Fakultna nemocnica s poliklinikou Nove Zamky
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Ljubljana, Slovenia, 1000
- Reclutamento
- Univerzitetni klinicni center Ljubljana
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Alabama
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Birmingham, Alabama, Stati Uniti, 35233
- Reclutamento
- The University of Alabama at Birmingham
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California
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Sacramento, California, Stati Uniti, 95817
- Reclutamento
- UC Davis School of Medicine
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Colorado
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Aurora, Colorado, Stati Uniti, 80045
- Reclutamento
- Childrens Hospital Colorado
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Florida
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Gainesville, Florida, Stati Uniti, 32611
- Reclutamento
- University of Florida at Shands
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Illinois
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Park Ridge, Illinois, Stati Uniti, 60068
- Reclutamento
- Advocate Children's Hospital
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Indiana
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Indianapolis, Indiana, Stati Uniti, 46202
- Sospeso
- Riley Children s Hospital
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Iowa
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Iowa City, Iowa, Stati Uniti, 52242
- Reclutamento
- University of Iowa Hospital and Clinics
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Michigan
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Detroit, Michigan, Stati Uniti, 48201
- Reclutamento
- Wayne State University
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New York
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Rochester, New York, Stati Uniti, 14642
- Reclutamento
- University of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 27599
- Reclutamento
- University of North Carolina at Chapel Hill
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45267
- Reclutamento
- University of Cincinnati
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Oregon
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Portland, Oregon, Stati Uniti, 97239
- Reclutamento
- Oregon Health And Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- Reclutamento
- Hospital of the University of Pennsylvania
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37232
- Reclutamento
- Vanderbilt University Medical Center
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Texas
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Galveston, Texas, Stati Uniti, 77555
- Reclutamento
- University of Texas Medical Branch
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Utah
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Salt Lake City, Utah, Stati Uniti, 84108
- Reclutamento
- University of Utah
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
Altri nomi:
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Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Platelet Count at Birth in a Neonate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Investigatori
- Direttore dello studio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Citopenia
- Infante, neonato, malattie
- Malattie ematologiche
- Disturbi delle piastrine del sangue
- Trombocitopenia
- Malattie e anomalie congenite, ereditarie e neonatali
- Malattie emiche e linfatiche
- Trombocitopenia, alloimmune neonatale
- Aminoacidi, peptidi e proteine
- Proteine
- Composti policiclici
- Anticorpi
- Immunoglobuline
- Immunoproteine
- Proteine del sangue
- Globuline sieriche
- Globuline
- Incinta
- In gravidanza
- Steroidi
- Composti anelli fusi
- Incintadienediols
- Isotipi di immunoglobulina
- Immunoglobulina g
- Prednisone
- Immunoglobuline, per via endovenosa
Altri numeri di identificazione dello studio
- 80202135FNAIT3003
- 2023-509434-19-00 (Identificatore di registro: EUCT number)
- 2023 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .