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Badanie nipokalimabu w ciążach zagrożonych ciężką chorobą hemolityczną płodu i noworodka (HDFN) (AZALEA)

2 listopada 2026 zaktualizowane przez: Janssen Research & Development, LLC

Randomizowane, kontrolowane placebo, podwójnie ślepe, wieloośrodkowe badanie fazy 3 oceniające skuteczność i bezpieczeństwo nipokalimabu w ciążach zagrożonych ciężką chorobą hemolityczną płodu i noworodka (HDFN)

The purpose of this study is to assess the effectiveness of nipocalimab when compared to placebo in decreasing the risk of fetal anemia (a condition in which a baby's red blood cell volume falls below normal levels while the baby is developing in the womb) with live neonates in pregnant participants at risk for severe hemolytic disease of the fetus and newborn.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

120

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Argentyna
      • Buenos Aires, Argentyna, C1199
        • Rekrutacyjny
        • Hospital Italiano de Buenos Aires
      • Córdoba, Argentyna, X5016KEH
        • Rekrutacyjny
        • Hospital Privado Universitario De Cordoba
  • Australia
      • South Brisbane, Australia, 4101
        • Rekrutacyjny
        • Mater Hospital Brisbane
      • Sydney, Australia, 2170
        • Rekrutacyjny
        • Liverpool Hospital
  • Austria
      • Graz, Austria, 8036
        • Rekrutacyjny
        • Medizinische Universitaet Graz
      • Vienna, Austria, 1090
        • Rekrutacyjny
        • Medizinische Universitaet Wien
  • Belgia
      • Brussels, Belgia, 1020
        • Rekrutacyjny
        • C.H.U. Brugmann
      • Leuven, Belgia, 3000
        • Rekrutacyjny
        • Universitair Ziekenhuis Leuven
  • Brazylia
      • Belo Horizonte, Brazylia, 30130 100
        • Rekrutacyjny
        • Faculdade de Medicina Universidade Federal de Minas Gerais
      • Goiânia, Brazylia, 74605 020
        • Rekrutacyjny
        • Hospital das Clinicas - UFG
      • Recife, Brazylia, 50070902
        • Rekrutacyjny
        • Instituto de Medicina Integral Professor Fernando Figueira
      • Rio de Janeiro, Brazylia, 22281 100
        • Rekrutacyjny
        • IDOR - Regional Rio de Janeiro
      • São Paulo, Brazylia, 05403-010
        • Rekrutacyjny
        • Hospital Das Clinicas Da Faculdade De Medicina Da USP
  • Francja
      • Bron, Francja, 69500
        • Rekrutacyjny
        • Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant
      • Lille, Francja, 59000
        • Rekrutacyjny
        • CHRU Lille
      • Paris, Francja, 75012
        • Rekrutacyjny
        • Hopital Armand Trousseau
  • Hiszpania
      • Barcelona, Hiszpania, 08035
        • Rekrutacyjny
        • Hosp Univ Vall D Hebron
      • Madrid, Hiszpania, 28046
        • Rekrutacyjny
        • Hosp. Univ. La Paz
      • Seville, Hiszpania, 41013
        • Rekrutacyjny
        • Hosp. Virgen Del Rocio
  • Holandia
      • Leiden, Holandia, 2333 ZA
        • Rekrutacyjny
        • Leiden University Medical Center
  • Irlandia
      • Dublin, Irlandia, D01 P5W9
        • Rekrutacyjny
        • Rotunda Hospital
  • Izrael
      • Jerusalem, Izrael, 91240
        • Rekrutacyjny
        • Hadassah mount scopus
      • Petah Tikva, Izrael, 49100
        • Rekrutacyjny
        • Rabin Medical Center
      • Ramat Gan, Izrael, 5265601
        • Rekrutacyjny
        • The Chaim Sheba Medical Center
  • Japonia
      • Fukuoka, Japonia, 812 8582
        • Zakończony
        • Kyushu University Hospital
      • Gifu, Japonia, 500-8717
        • Rekrutacyjny
        • Gifu Prefectural General Medical Center
      • Izumi-shi, Japonia, 594-1101
        • Rekrutacyjny
        • Osaka Womens and Childrens Hospital
      • Sendai, Japonia, 989-3126
        • Zakończony
        • Miyagi Childrens Hospital
      • Ōta-ku, Japonia, 143-8541
        • Rekrutacyjny
        • Toho University Medical Center Omori Hospital
  • Kanada
    • British Columbia
      • Vancouver, British Columbia, Kanada, V6H 3N1
        • Rekrutacyjny
        • BC Women's Hospital University of British Columbia
    • Ontario
      • Toronto, Ontario, Kanada, M5G 1X5
        • Rekrutacyjny
        • Mount Sinai Hospital
    • Quebec
      • Montreal, Quebec, Kanada, H4A 3J1
        • Rekrutacyjny
        • McGill University Health Centre
      • Montreal, Quebec, Kanada, H3T 1C5
        • Rekrutacyjny
        • Centre Hospitalier Sainte Justine
  • Niemcy
      • Berlin, Niemcy, 10117
        • Rekrutacyjny
        • Charite Universitaetsmedizin Berlin
      • Giessen, Niemcy, 35392
        • Rekrutacyjny
        • Universitaetsklinikum Giessen und Marburg Standort Giessen
      • Hamburg, Niemcy, 20251
        • Rekrutacyjny
        • Universitaetsklinikum Hamburg Eppendorf
  • Polska
      • Lodz, Polska, 93 338
        • Rekrutacyjny
        • Instytut Centrum Zdrowia Matki Polki
      • Warsaw, Polska, 01 211
        • Rekrutacyjny
        • Instytut Matki i Dziecka
      • Warsaw, Polska, 02 507
        • Rekrutacyjny
        • Panstwowy Instytut Medyczny MSWiA w Warszawie
  • Stany Zjednoczone
    • California
      • La Jolla, California, Stany Zjednoczone, 92037
        • Rekrutacyjny
        • University of California at San Diego
      • Los Angeles, California, Stany Zjednoczone, 90027
        • Rekrutacyjny
        • Kaiser Permanente Los Angeles Medical Center
      • Sacramento, California, Stany Zjednoczone, 95817
        • Rekrutacyjny
        • UC Davis School of Medicine
    • Colorado
      • Aurora, Colorado, Stany Zjednoczone, 80045
        • Rekrutacyjny
        • Childrens Hospital Colorado
    • Florida
      • Miami, Florida, Stany Zjednoczone, 33136
        • Rekrutacyjny
        • University of Miami
    • Illinois
      • Park Ridge, Illinois, Stany Zjednoczone, 60068
        • Rekrutacyjny
        • Advocate Children's Hospital
    • Indiana
      • Indianapolis, Indiana, Stany Zjednoczone, 46202
        • Zawieszony
        • Riley Children s Hospital
    • Iowa
      • Iowa City, Iowa, Stany Zjednoczone, 52242
        • Rekrutacyjny
        • University of Iowa
    • Kentucky
      • Lexington, Kentucky, Stany Zjednoczone, 40536
        • Rekrutacyjny
        • University of Kentucky Medical Center
    • Maryland
      • Baltimore, Maryland, Stany Zjednoczone, 21287
        • Rekrutacyjny
        • Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02115
        • Rekrutacyjny
        • Boston Childrens Hospital
    • Minnesota
      • Minneapolis, Minnesota, Stany Zjednoczone, 55404
        • Rekrutacyjny
        • Midwest Fetal Care Center
    • New York
      • New York, New York, Stany Zjednoczone, 10032
        • Rekrutacyjny
        • Columbia University Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Stany Zjednoczone, 27599-7516
        • Rekrutacyjny
        • University of North Carolina (UNC) - School of Medicine
    • Ohio
      • Cincinnati, Ohio, Stany Zjednoczone, 45267
        • Rekrutacyjny
        • University of Cincinnati
    • Oregon
      • Portland, Oregon, Stany Zjednoczone, 97239
        • Rekrutacyjny
        • Oregon Health and Science University
    • Pennsylvania
      • Allentown, Pennsylvania, Stany Zjednoczone, 18103-6218
        • Rekrutacyjny
        • Lehigh Valley Hospital
    • Texas
      • Austin, Texas, Stany Zjednoczone, 78723
        • Rekrutacyjny
        • University of Texas Dell Medical School Department of Women's Health
      • Galveston, Texas, Stany Zjednoczone, 77555
        • Rekrutacyjny
        • University Of Texas Medical Branch At Galveston
    • Utah
      • Murray, Utah, Stany Zjednoczone, 84107
        • Rekrutacyjny
        • Intermountain Medical Center
    • Virginia
      • Norfolk, Virginia, Stany Zjednoczone, 23507
        • Rekrutacyjny
        • Macon & Joan Brock Virginia Health Sciences at Old Dominion University
    • Washington
      • Seattle, Washington, Stany Zjednoczone, 98105
        • Rekrutacyjny
        • Seattle Children's Hospital
  • Szwecja
      • Stockholm, Szwecja, 14186
        • Rekrutacyjny
        • Karolinska Universitetssjukhuset Huddinge
  • Włochy
      • Roma, Włochy, 00168
        • Rekrutacyjny
        • Fondazione Policlinico Universitario A Gemelli IRCCS
  • Zjednoczone Królestwo
      • Birmingham, Zjednoczone Królestwo, B15 2TG
        • Rekrutacyjny
        • Birmingham Women's Hospital
      • Leeds, Zjednoczone Królestwo, LS9 7TF
        • Rekrutacyjny
        • Leeds Teaching Hospitals NHS Trust
      • London, Zjednoczone Królestwo, SE5 9RS
        • Rekrutacyjny
        • Kings College Hospital
      • London, Zjednoczone Królestwo, SW17 0QT
        • Rekrutacyjny
        • St Georges Hospital
      • Manchester, Zjednoczone Królestwo, M13 9WL
        • Rekrutacyjny
        • St.Mary's Hospital
      • Oxford, Zjednoczone Królestwo, OX3 9DU
        • Rekrutacyjny
        • John Radcliffe Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 45 lat (Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Kobieta

Opis

Inclusion Criteria:

  • Pregnant and an estimated gestational age (GA) (based on ultrasound dating) from Week 13^0/7 to Week 18^6/7 at randomization

  • History of severe Hemolytic Disease of the Fetus and Newborn (HDFN) in a prior pregnancy defined as documented:

    1. fetal anemia as result of HDFN or fetal hydrops as result of HDFN or received greater than or equal to (>=)1 IUT as a result of HDFN or
    2. fetal loss or neonatal death as a result of HDFN, with maternal alloantibody titers for Rhesus antigen D protein (RhD), Kell, Kell Rhesus antigen C protein (Rhc), Rhesus antigen E protein (RhE), or RhC antigen above the critical levels (anti-Kell >=4; other >=16) and evidence of an antigen-positive fetus

  • During the current pregnancy, presence of maternal alloantibody to RhD, Rhc, RhE, or RhC antigen with titers above the critical level (anti-Kell >= 4; other >=16) based on the designated central lab results at screening

  • Evidence of antigen-positivity corresponding to the current maternal alloantibody (RhD, Kell, Rhc, RhE, or RhC) confirmed by non-invasive antigen cell-free fetal DNA (cffDNA) performed at the central laboratory

  • Have screening lab test results within values within the study protocol-specified parameters: a) albumin >= lower limit of normal (LLN); b) alanine transaminase (AST) less than or equal to (<=) 2 × upper limit of normal (ULN); c) alanine transaminase (ALT) <=2 × ULN d) creatinine <=0.8 milligrams per deciliter (mg/dL), SI: <=70.7 micromole per liter (μmol/L), and Serum total immunoglobulins G (IgG) ≥ 600 mg/dL SI: >=6 g/L

  • Medically stable on the basis of physical examination, medical history, vital signs, 12-lead ECG, and clinical lab tests performed at screening

Exclusion Criteria:

  • Currently pregnant with a multiple gestation (twins or more)
  • Evidence of fetal anemia prior to randomization in the current pregnancy
  • History of severe preeclampsia prior to GA Week 34 or severe fetal growth restriction (estimated fetal weight <3rd percentile, based on local fetal growth normative standards) in a previous pregnancy
  • Current uncontrolled hypertension
  • History of myocardial infarction, unstable ischemic heart disease, or stroke
  • Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
  • Has inflammatory or autoimmune diseases requiring immunosuppressive therapies that may jeopardize the safety of the participant
  • Currently has a malignancy or has a history of malignancy within 3 years before screening (with the exception of localized basal cell carcinoma and/or squamous cell carcinoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study intervention administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study intervention)
  • Is currently receiving systemic corticosteroids or other immunosuppressants for disorders unrelated to the pregnancy
  • Has received or planning to receive plasmapheresis, immunoadsorption therapy, intravenous immunoglobulin (IV Ig), or any immunoglobulin (Ig)G fragment crystallizable (Fc)-related protein therapeutics during the current pregnancy
  • Has a severe infection including opportunistic infections
  • Presence of abnormal (protocol-specified) hematologic lab values during screening
  • History of an unprovoked pulmonary embolism or history of recurrent deep vein thrombosis (DVT)

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Nipocalimab

Participants will receive nipocalimab intravenously (IV) once weekly (qw) from randomization through gestational age (GA) Week 35.
Lek: Nipocalimab

Nipocalimab will be administered as an intravenous infusion.

Inne nazwy:
  • JNJ-80202135
  • M281
  • JNJ-86507083
Komparator placebo: Placebo

Participants will receive matching placebo IV qw from randomization through GA Week 35.
Lek: Placebo

Placebo will be administered as an intravenous infusion.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Pregnancies That did not Result in Fetal Loss, Intrauterine Transfusion (IUT), Hydrops Fetalis, or Neonatal Death
Ramy czasowe: From randomization in the study through 4 weeks of age or 41 weeks Postmenstrual Age (PMA) during neonatal period, whichever is later

Percentage of pregnancies that did not result in fetal loss, IUT, hydrops fetalis, or neonatal death (during the neonatal period) will be reported. Hydrops fetalis is defined as the presence of greater than or equal to(>=)2 abnormal fluid collections in the fetus or neonate, such as ascites, pleural effusions, pericardial effusion, and generalized skin edema (skin thickness greater (>)5 millimeter [mm]). PMA is the time elapsed between the first day of the last menstrual period and birth (gestational age) plus the time elapsed after birth (chronological age).
From randomization in the study through 4 weeks of age or 41 weeks Postmenstrual Age (PMA) during neonatal period, whichever is later

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants With Hemolytic Disease of the Fetus and Newborn (HDFN) by Severity
Ramy czasowe: For first database lock: from randomization in the study through 4 weeks of age or 41 weeks PMA during neonatal period, whichever is later for the first database lock; for second database lock: through 12 weeks after birth

Number of participants with HDFN by severity will be reported. The severity of HDFN is defined as: 5 (fatal): fetal or neonatal death due to any reason; 4 (severe): hydrops fetalis (in fetus or newborn) or receiving IUT during pregnancy as a result of HDFN but not 5 (fatal); 3 (moderate): neonatal exchange transfusions received as a result of HDFN related hemolysis and jaundice but not 4 (severe) or 5 (fatal); 2 (mild): neonatal simple transfusions received due to HDFN after birth, with or without phototherapy, but not 3 (moderate), 4 (severe), or 5 (fatal); and 1 (minimal or none): not in 2 (mild), 3 (moderate), 4 (severe), or 5 (fatal) as described above. Here database lock implies the last participant has given birth or terminated their pregnancy, completed the Week 4 visit after delivery, and whose neonate has also completed the Week 4 visit (or 41 weeks PMA, whichever is later) or died prior to this timepoint.
For first database lock: from randomization in the study through 4 weeks of age or 41 weeks PMA during neonatal period, whichever is later for the first database lock; for second database lock: through 12 weeks after birth
Time to First Occurrence of IUT or Hydrops Fetalis
Ramy czasowe: From randomization to delivery of baby (Up to 38 weeks)

Time to first occurrence of IUT or hydrops fetalis will be reported.
From randomization to delivery of baby (Up to 38 weeks)
Neonatal Mortality and Morbidity Index (NMMI) in Liveborn Neonates
Ramy czasowe: Through 38 weeks PMA or at discharge if earlier than 38 weeks PMA

The NMMI will be assessed with the following categories: fatal: fetal/neonatal death; major morbidity: any of intraventricular hemorrhage grade 3/4, seizures, hypoxic-ischemic encephalopathy, necrotizing enterocolitis stage 2/3, respiratory distress syndrome requiring mechanical ventilation, bronchopulmonary dysplasia requiring oxygen support, or persistent pulmonary hypertension; Minor morbidity: anemia requiring simple transfusion, hyperbilirubinemia requiring an exchange transfusion, hypotension requiring treatment, intraventricular hemorrhage grade 1/2, necrotizing enterocolitis stage 1, or respiratory distress syndrome not requiring mechanical ventilation; None: no major or minor morbidities described above. Hyperbilirubinemia requiring phototherapy will be classified in this category'
Through 38 weeks PMA or at discharge if earlier than 38 weeks PMA
Number of IUT's Received During the Pregnancy
Ramy czasowe: From randomization to delivery of baby (Up to 38 weeks)

Number of IUT's received during the pregnancy will be reported.
From randomization to delivery of baby (Up to 38 weeks)
Percentage of Pregnancies With Fetal Loss
Ramy czasowe: Time to delivery of baby (Up to 38 weeks)

Percentage of pregnancies with fetal loss will be reported.
Time to delivery of baby (Up to 38 weeks)
Percentage of Pregnancies With Fetal or Neonatal Death
Ramy czasowe: Through Week 4 or 41 weeks PMA

Percentage of pregnancies with fetal or neonatal death (through the neonatal period) as a result of HDFN will be reported.
Through Week 4 or 41 weeks PMA
Percentage of Pregnancies With Hydrops Fetalis
Ramy czasowe: Up to 41 weeks PMA

Percentage of pregnancies with hydrops fetalis will be reported. Hydrops fetalis is defined as the presence of >=2 abnormal fluid collections in the fetus or neonate, such as ascites, pleural effusions, pericardial effusion, and generalized skin edema (skin thickness >5 mm).
Up to 41 weeks PMA
Percentage of Pregnancies Receiving IUT During Pregnancy
Ramy czasowe: Up to 35 weeks of GA period

Percentage of pregnancies receiving IUT during pregnancy will be reported.
Up to 35 weeks of GA period
Gestational Age (GA) at First IUT
Ramy czasowe: Up to 35 weeks of GA period

GA at first IUT will be reported.
Up to 35 weeks of GA period
Percentage of Pregnancies Receiving >1 IUT During Pregnancy
Ramy czasowe: Up to 35 weeks of GA period

Percentage of pregnancies receiving >1 IUT during pregnancy will be reported.
Up to 35 weeks of GA period
Percentage of Pregnancies Receiving IUT or HDFN Resulting in Fetal Demise (Less Than) <GA Week 20
Ramy czasowe: Up to 20 weeks

Percentage of pregnancies receiving IUT or HDFN resulting in fetal demise <GA Week 20 will be reported.
Up to 20 weeks
Gestational Age at Delivery
Ramy czasowe: Up to 38 weeks

Gestational age at delivery will be reported.
Up to 38 weeks
Percentage of Pregnancies With Neonatal Death Through the Neonatal Period
Ramy czasowe: From randomization in the study through 4 weeks of age or 41 weeks PMA during neonatal period, whichever is later

Percentage of pregnancies with neonatal death through the neonatal period will be reported.
From randomization in the study through 4 weeks of age or 41 weeks PMA during neonatal period, whichever is later
Percentage of Liveborn Neonates With HDFN-related Morbidities Other Than Anemia and Hyperbilirubinemia or Jaundice
Ramy czasowe: From day of birth up to 4 weeks

Percentage of liveborn neonates with HDFN-related morbidities other than anemia and hyperbilirubinemia or jaundice will be reported.
From day of birth up to 4 weeks
Absolute Weight of Liveborn Neonates or Infants
Ramy czasowe: Up to 104 weeks

Absolute weight of liveborn neonates or infants will be reported.
Up to 104 weeks
Change From Baseline in Weight of Liveborn Neonates or Infants
Ramy czasowe: Baseline to up to 104 weeks

Change from baseline in weight of liveborn neonates or infants will be reported.
Baseline to up to 104 weeks
Liveborn Neonates Length of Stay in Neonatal Intensive Care Unit
Ramy czasowe: From day of birth up to 27 days

Liveborn neonates length of stay in neonatal intensive care unit will be reported.
From day of birth up to 27 days
Percentage of Liveborn Neonates Receiving Exchange Transfusions for HDFN
Ramy czasowe: From day of birth up to 27 days

Percentage of liveborn neonates receiving exchange transfusions for HDFN will be reported.
From day of birth up to 27 days
Number of Neonatal Exchange Transfusions per Liveborn Neonate
Ramy czasowe: From day of birth up to 27 days

Number of neonatal exchange transfusions per liveborn neonate will be reported.
From day of birth up to 27 days
Percentage of Liveborn Neonates or Infants with Simple Transfusions for HDFN
Ramy czasowe: For first database lock: From birth up to 4 weeks; for second database lock: From birth up to 12 weeks

Percentage of liveborn neonates or infants with simple transfusions for HDFN through the neonatal period (for the first database lock) or 12 weeks (for the second database lock) after birth will be reported.
For first database lock: From birth up to 4 weeks; for second database lock: From birth up to 12 weeks
Number of Simple Transfusions for HDFN per Liveborn Neonate or Infant
Ramy czasowe: For first database lock: From birth up to 4 weeks; for second database lock: From birth up to 12 weeks

Number of simple transfusions for HDFN per liveborn neonate or infant through the neonatal period (for the first database lock) or 12 weeks (for the second database lock) after birth will be reported.
For first database lock: From birth up to 4 weeks; for second database lock: From birth up to 12 weeks
Percentage of Liveborn Neonates With Hyperbilirubinemia Treated With Phototherapy
Ramy czasowe: From day of birth up to 27 days

Percentage of liveborn neonates with hyperbilirubinemia treated with phototherapy will be reported.
From day of birth up to 27 days
Number of Days of Phototherapy Received for Hyperbilirubinemia per Liveborn Neonate
Ramy czasowe: From day of birth up to 27 days

Number of days of phototherapy received for hyperbilirubinemia per liveborn neonate will be reported.
From day of birth up to 27 days
Percentage of Liveborn Neonates or Infants Receiving Intravenous Immunoglobulin (IVIg) for HDFN Treatment
Ramy czasowe: For first database lock: From birth up to 4 weeks; for second database lock: From birth up to 12 weeks

Percentage of liveborn neonates or infants receiving IVIg for HDFN treatment will be reported.
For first database lock: From birth up to 4 weeks; for second database lock: From birth up to 12 weeks
Number of Maternal Deaths
Ramy czasowe: Form randomization up to 24 weeks postpartum

Number of maternal deaths will be reported.
Form randomization up to 24 weeks postpartum
Number of Participants with Adverse Events (AEs)
Ramy czasowe: From randomization up to 24 weeks postpartum

Number of participants with AEs, serious adverse events, and AEs of special interest (AESIs), AE's leading to discontinuations, infections, serious infections, infusion reactions, and hypersensitivity reactions will be reported. Treatment-emergent adverse events associated with the following situations are considered as AESIs: hypoalbuminemia, clinically significant bleeding with a corresponding placental finding on ultrasound, maternal infections that led to clinically significant morbidities or mortalities in fetus or neonates, Infections that are severe or require intravenous (IV) anti-infective or operative or invasive intervention in maternal participants or neonates or infants, and infants with hypogammaglobulinemia.
From randomization up to 24 weeks postpartum
Number of Maternal Pregnancy Complications
Ramy czasowe: Up to 38 weeks

Number of maternal pregnancy complications will be reported.
Up to 38 weeks
Number of IUT Related complications
Ramy czasowe: Up to 35 weeks of GA period

Number of participants with IUT related complications will be reported.
Up to 35 weeks of GA period
Percentage of Pregnancies With Cesarean Delivery, Preterm Birth, Fetal Growth, and Preeclampsia
Ramy czasowe: Up to 38 weeks of GA period

Percentage of pregnancies with cesarean delivery, cesarean delivery due to IUT complications, preterm birth <GA week 28, preterm birth <GA week 32, preterm birth <GA week 34, preterm birth <GA week 37, fetal growth restriction, and preeclampsia will be reported.
Up to 38 weeks of GA period
Percentage of Liveborn Neonates or Infants Who Died
Ramy czasowe: Up to 104 weeks

Percentage of liveborn neonates or infants who died will be reported.
Up to 104 weeks
Percentage of Liveborn Neonates or Infants With AEs
Ramy czasowe: Up to 104 weeks

Percentage of liveborn neonates or infants with AEs, SAEs, AESIs, infections, serious infections will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. Any event requiring hospitalization (or prolongation of hospitalization) that occurs during participation in the study must be reported as an SAE.
Up to 104 weeks
Percentage of Liveborn Neonates or Infants Receiving IVIg for Non-HDFN Indications
Ramy czasowe: Up to 104 weeks

Percentage of liveborn neonates or infants receiving IVIg for non-HDFN indications will be reported.
Up to 104 weeks
Percentage of Liveborn Neonates or Infants With Abnormal Hearing
Ramy czasowe: Up to 104 weeks

Percentage of liveborn neonates or infants with abnormal hearing will be reported.
Up to 104 weeks
Bayley Scales of Infant Development and Toddler Development
Ramy czasowe: Week 52 and 104

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 (3rd edition) 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.
Week 52 and 104
Change From Baseline in Generalized Anxiety Disorder 7-Item (GAD7) Over time During Pregnancy and Postpartum
Ramy czasowe: Baseline (Day 1) and Week 30 during pregnancy and Week 4 postpartum

Change from baseline in GAD7 over time during pregnancy and postpartum will be reported. The GAD-7 scale is a self-administered questionnaire designed to measure anxiety. The recall period for all items is the past 2 weeks. Responses to all items are rated on a 4-point Likert scale ranging from 0 "not at all" to 3 "nearly every day". The total score ranges from 0 to 21, with higher scores indicating higher severity of anxiety symptoms.
Baseline (Day 1) and Week 30 during pregnancy and Week 4 postpartum
Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Score
Ramy czasowe: Baseline (Day 1) and Week 30 during pregnancy and Week 4 postpartum

Change from baseline in SF-36v2 acute form domain score will be reported. The SF-36 version 2 acute is a self-administered, 36-item questionnaire measuring health-related quality of life and includes 8 domains that measure physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality social functioning, role limitations due to emotional problems, and mental health. The 8 domains can be aggregated into 2 summary scales that reflect physical and mental health: a physical component summary and a mental component summary. Responses to all items are rated on a 3, 5, or 6-point Likert scale, with higher scores indicating better health status.
Baseline (Day 1) and Week 30 during pregnancy and Week 4 postpartum
Change From Baseline in EuroQol Five-dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score
Ramy czasowe: Baseline (Day 1) and Week 30 during pregnancy and Week 4 postpartum

Change from baseline in EQ-5D-5L visual analogue score will be reported. The EQ-5D descriptive system is comprised of 5 items across the following 5 dimensions: mobility, self-care, usual activities, pain or discomfort and anxiety or depression. The EQ-5D-5L uses a 5-point Likert response scale ranging from "no problems" to "extreme problems", with higher scores indicating better quality of life. EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ-VAS). EQ-VAS score ranges from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state. Higher score indicates good health state.
Baseline (Day 1) and Week 30 during pregnancy and Week 4 postpartum
Change From Baseline in EuroQol 5-Dimension Descriptive (EQ-5D) Index Score
Ramy czasowe: Baseline (Day 1) and Week 30 during pregnancy and Week 4 postpartum

Change from baseline in EQ-5D index score will be reported. The EQ-5D descriptive system is comprised of 5 items across the following 5 dimensions: mobility, self-care, usual activities, pain or discomfort and anxiety or depression. The EQ-5D-5L descriptive system uses a 5-point Likert response scale ranging from "no problems" to "extreme problems", with higher scores indicating better quality of life.
Baseline (Day 1) and Week 30 during pregnancy and Week 4 postpartum
Infant Health-Related Quality of Life Instrument (IQI) Score for Neonate or Infant Overtime
Ramy czasowe: Weeks 4, 8 and 52

IQI score for neonate or infant will be reported. The IQI consists of 7 health attributes including sleeping, feeding, breathing, stooling or poo, mood, skin, and interaction. Responses to all items are rated on a 4-point Likert scale, with higher scores indicating better quality of life.
Weeks 4, 8 and 52

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Janssen Research & Development, LLC

Śledczy

  • Dyrektor Studium: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

20 grudnia 2023

Zakończenie podstawowe (Szacowany)

5 sierpnia 2027

Ukończenie studiów (Szacowany)

8 października 2029

Daty rejestracji na studia

Pierwszy przesłany

13 czerwca 2023

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 czerwca 2023

Pierwszy wysłany (Rzeczywisty)

22 czerwca 2023

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

3 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • CR109199
  • 2021-002359-12 (Numer EudraCT)
  • 80202135EBF3001 (Inny identyfikator: Janssen Research & Development, LLC)
  • 2022-502629-16-00 (Identyfikator rejestru: EUCT number)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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