A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
Condition(s) studied
Investigational drug(s) / intervention(s)
Nipocalimab: Nipocalimab will be administered as an intravenous infusion.
Placebo: Placebo will be administered as an intravenous infusion.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Percentage of Pregnancies That did not Result in Fetal Loss, Intrauterine Transfusion (IUT), Hydrops Fetalis, or Neonatal Death — 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).
Trial sites (65)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California at San Diego | La Jolla | California | Recruiting |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | Recruiting |
| UC Davis School of Medicine | Sacramento | California | Recruiting |
| Childrens Hospital Colorado | Aurora | Colorado | Recruiting |
| University of Miami | Miami | Florida | Recruiting |
| Advocate Children's Hospital | Park Ridge | Illinois | Recruiting |
| Riley Children s Hospital | Indianapolis | Indiana | Suspended |
| University of Iowa | Iowa City | Iowa | Recruiting |
| University of Kentucky Medical Center | Lexington | Kentucky | Recruiting |
| Johns Hopkins Hospital | Baltimore | Maryland | Recruiting |
| Boston Childrens Hospital | Boston | Massachusetts | Recruiting |
| Midwest Fetal Care Center | Minneapolis | Minnesota | Recruiting |
| Columbia University Medical Center | New York | New York | Recruiting |
| University of North Carolina (UNC) - School of Medicine | Chapel Hill | North Carolina | Recruiting |
| University of Cincinnati | Cincinnati | Ohio | Recruiting |
| Oregon Health and Science University | Portland | Oregon | Recruiting |
| Lehigh Valley Hospital | Allentown | Pennsylvania | Recruiting |
| University of Texas Dell Medical School Department of Women's Health | Austin | Texas | Recruiting |
| University Of Texas Medical Branch At Galveston | Galveston | Texas | Recruiting |
| Intermountain Medical Center | Murray | Utah | Recruiting |
| Macon & Joan Brock Virginia Health Sciences at Old Dominion University | Norfolk | Virginia | Recruiting |
| Hospital Italiano de Buenos Aires | Buenos Aires | Argentina | Recruiting |
| Hospital Privado Universitario De Cordoba | Córdoba | Argentina | Recruiting |
| Mater Hospital Brisbane | South Brisbane | Australia | Recruiting |
| Liverpool Hospital | Sydney | Australia | Recruiting |
| Medizinische Universitaet Graz | Graz | Austria | Recruiting |
| Medizinische Universitaet Wien | Vienna | Austria | Recruiting |
| C.H.U. Brugmann | Brussels | Belgium | Recruiting |
| Universitair Ziekenhuis Leuven | Leuven | Belgium | Recruiting |
| Faculdade de Medicina Universidade Federal de Minas Gerais | Belo Horizonte | Brazil | Recruiting |
| Hospital das Clinicas - UFG | Goiânia | Brazil | Recruiting |
| Instituto de Medicina Integral Professor Fernando Figueira | Recife | Brazil | Recruiting |
| IDOR - Regional Rio de Janeiro | Rio de Janeiro | Brazil | Recruiting |
| Hospital Das Clinicas Da Faculdade De Medicina Da USP | São Paulo | Brazil | Recruiting |
| BC Women's Hospital University of British Columbia | Vancouver | British Columbia | Recruiting |
| Mount Sinai Hospital | Toronto | Ontario | Recruiting |
| Centre Hospitalier Sainte Justine | Montreal | Quebec | Recruiting |
| McGill University Health Centre | Montreal | Quebec | Recruiting |
| Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant | Bron | France | Recruiting |
| CHRU Lille | Lille | France | Recruiting |
+ 25 more sites — see the full list on the official registry below.
More Janssen Research & Development, LLC trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05912517 on ClinicalTrials.gov ↗ ← All trials in Italy