Eine Studie zu Nipocalimab oder intravenösem Immunglobulin (IVIG) bei Schwangerschaften mit dem Risiko einer fetalen und neonatalen alloimmunen Thrombozytopenie (FNAIT) (FREESIA-3)
Multizentrische, offene, randomisierte Studie zu Nipocalimab oder intravenösem Immunglobulin (IVIG) bei Schwangerschaften mit dem Risiko einer fetalen und neonatalen Alloimmunthrombozytopenie (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).
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 3
Kontakte und Standorte
Studienkontakt
- Name: Study Contact
- Telefonnummer: 844-434-4210
- E-Mail: Participate-In-This-Study1@its.jnj.com
Studienorte
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Leuven, Belgien, 3000
- Rekrutierung
- Universitair Ziekenhuis Leuven
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Berlin, Deutschland, 10117
- Rekrutierung
- Charite Universitaetsmedizin Berlin
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Giessen, Deutschland, 35392
- Rekrutierung
- Universitaetsklinikum Giessen und Marburg GmbH
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Hanover, Deutschland, 30625
- Rekrutierung
- Medizinische Hochschule Hannover
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Jena, Deutschland, 07747
- Rekrutierung
- Universitatsklinikum Jena
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Tübingen, Deutschland, 72076
- Rekrutierung
- Universitaetsklinikum Tuebingen
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Ramat Gan, Israel, 5262000
- Rekrutierung
- Sheba Medical Center
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Milan, Italien, 20122
- Rekrutierung
- Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
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Roma, Italien, 00168
- Rekrutierung
- Fondazione Policlinico Universitario A Gemelli IRCCS
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Leiden, Niederlande, 2333 ZA
- Rekrutierung
- Leiden University Medical Center
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Lodz, Polen, 93 338
- Rekrutierung
- Instytut Centrum Zdrowia Matki Polki
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Warsaw, Polen, 01 211
- Rekrutierung
- Instytut Matki i Dziecka
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Warsaw, Polen, 02 507
- Rekrutierung
- Panstwowy Instytut Medyczny MSWiA w Warszawie
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Košice, Slowakei, 040 11
- Rekrutierung
- Univerzitna nemocnica L. Pasteura Kosice
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Nové Zámky, Slowakei, 940 34
- Rekrutierung
- Fakultna nemocnica s poliklinikou Nove Zamky
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Ljubljana, Slowenien, 1000
- Rekrutierung
- Univerzitetni klinicni center Ljubljana
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35233
- Rekrutierung
- The University of Alabama at Birmingham
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California
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Sacramento, California, Vereinigte Staaten, 95817
- Rekrutierung
- UC Davis School of Medicine
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Colorado
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Aurora, Colorado, Vereinigte Staaten, 80045
- Rekrutierung
- Childrens Hospital Colorado
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Florida
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Gainesville, Florida, Vereinigte Staaten, 32611
- Rekrutierung
- University of Florida at Shands
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Illinois
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Park Ridge, Illinois, Vereinigte Staaten, 60068
- Rekrutierung
- Advocate Children's Hospital
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Indiana
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Indianapolis, Indiana, Vereinigte Staaten, 46202
- Suspendiert
- Riley Children s Hospital
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Iowa
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Iowa City, Iowa, Vereinigte Staaten, 52242
- Rekrutierung
- University of Iowa Hospital and Clinics
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Michigan
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Detroit, Michigan, Vereinigte Staaten, 48201
- Rekrutierung
- Wayne State University
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New York
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Rochester, New York, Vereinigte Staaten, 14642
- Rekrutierung
- University of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, Vereinigte Staaten, 27599
- Rekrutierung
- University of North Carolina at Chapel Hill
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Ohio
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Cincinnati, Ohio, Vereinigte Staaten, 45267
- Rekrutierung
- University of Cincinnati
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Oregon
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Portland, Oregon, Vereinigte Staaten, 97239
- Rekrutierung
- Oregon Health And Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
- Rekrutierung
- Hospital of the University of Pennsylvania
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Tennessee
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Nashville, Tennessee, Vereinigte Staaten, 37232
- Rekrutierung
- Vanderbilt University Medical Center
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Texas
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Galveston, Texas, Vereinigte Staaten, 77555
- Rekrutierung
- University of Texas Medical Branch
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Utah
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Salt Lake City, Utah, Vereinigte Staaten, 84108
- Rekrutierung
- University of Utah
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Birmingham, Vereinigtes Königreich, B15 2TG
- Rekrutierung
- Birmingham Women's Hospital
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Liverpool, Vereinigtes Königreich, L8 7SS
- Rekrutierung
- Liverpool Women's NHS Foundation Trust - Liverpool Women's Hospital
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London, Vereinigtes Königreich, W12 0HS
- Rekrutierung
- Queen Charlotte's and Chelsea Hospital
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Oxford, Vereinigtes Königreich, OX3 9DU
- Rekrutierung
- John Radcliffe Hospital
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Graz, Österreich, 8036
- Rekrutierung
- Medizinische Universitaet Graz
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Vienna, Österreich, 1090
- Rekrutierung
- Medical University Vienna
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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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.
Andere Namen:
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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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Platelet Count at Birth in a Neonate
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to Week 4
|
Incidence of antibodies to nipocalimab including neutralizing antibodies in maternal serum during pregnancy and postpartum will be reported. |
Up to Week 4
|
Mitarbeiter und Ermittler
Ermittler
- Studienleiter: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Zytopenie
- Säugling, Neugeborenes, Krankheiten
- Hämatologische Erkrankungen
- Erkrankungen der Blutplättchen
- Thrombozytopenie
- Angeborene, erbliche und neonatale Krankheiten und Anomalien
- Hämische und lymphatische Krankheiten
- Thrombozytopenie, neonatale Alloimmunität
- Aminosäuren, Peptide und Proteine
- Proteine
- Polycyclische Verbindungen
- Antikörper
- Immunglobuline
- Immunoproteine
- Blutproteine
- Serumglobuline
- Globuline
- Schwangerschaft
- Schwangerschaft
- Steroide
- Fusions-Ring-Verbindungen
- Schwangerschaften
- Immunglobulinisotypen
- Immunglobulin g
- Prednison
- Immunglobuline, intravenös
Andere Studien-ID-Nummern
- 80202135FNAIT3003
- 2023-509434-19-00 (Registrierungskennung: EUCT number)
- 2023 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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
Arzneimittel- und Geräteinformationen, Studienunterlagen
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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