A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN) (AZALEA)
Last Updated August 23, 2024
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CR109199
OVERVIEW
-
Sexes Eligible for Study
female -
Age
years -
Phase
phase 33 -
Sites
Sites -
Status
Recruiting
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.
CONDITIONS
- Hemolytic Disease of the Fetus and Newborn
ELIGIBILITY
Inclusion Criteria:
* Pregnant and an estimated gestational age (GA) (based on ultrasound dating) from Week 13^0/7 to Week 16^6/7 at randomization
* History of severe Hemolytic Disease of the Fetus and Newborn (HDFN) in a prior pregnancy defined as:
1. documented fetal an
DETAILS
LOCATIONS
| Country (11) | City or Province (28) | Status |
| United States | Park Ridge Advocate Children's Hospital |
RECRUITING
|
| United States | Chapel Hill University of North Carolina (UNC) - School of Medicine |
RECRUITING
|
| United States | Austin University of Texas Dell Medical School Department of Women's Health |
RECRUITING
|
| United States | Galveston University Of Texas Medical Branch At Galveston |
RECRUITING
|
| Australia | South Brisbane Mater Hospital Brisbane |
RECRUITING
|
| Belgium | Bruxelles C.H.U. Brugmann |
RECRUITING
|
| Belgium | Leuven Universitair Ziekenhuis Leuven |
RECRUITING
|
| Brazil | Belo Horizonte Universidade Federal De Minas Gerais |
RECRUITING
|
| Brazil | Goiania Empresa Brasileira de Servicos Hospitalares EBSERH Hospital das Clinicas da UFG |
RECRUITING
|
| Brazil | Recife Instituto de Medicina Integral Professor Fernando Figueira |
RECRUITING
|
| Brazil | Sao Paulo Hospital Das Clinicas Da Faculdade De Medicina Da USP |
RECRUITING
|
| Germany | Giessen Universitatsklinikum Gießen und Marburg / Standort Gießen |
RECRUITING
|
| Israel | Petah Tikva Rabin Medical Center |
RECRUITING
|
| Israel | Ramat Gan The Chaim Sheba Medical Center |
RECRUITING
|
| Japan | Gifu Gifu Prefectural General Medical Center |
RECRUITING
|
| Netherlands | Leiden Leiden University Medical Center |
RECRUITING
|
| United Kingdom | Birmingham Birmingham Women's Hospital |
RECRUITING
|
| United Kingdom | Manchester St.Mary's Hospital |
RECRUITING
|
| Argentina | Buenos Aires Hospital Italiano de Buenos Aires |
RECRUITING
|
| Argentina | Ciudad Autonoma Buenos Aires CEMIC Saavedra |
SUSPENDED
|
| Australia | Sydney Liverpool Hospital |
RECRUITING
|
| Brazil | Rio de Janeiro Instituto D Or de Pesquisa e Ensino IDOR |
RECRUITING
|
| Japan | Fukuoka Kyushu University Hospital |
RECRUITING
|
| Japan | Sendai Miyagi Children's Hospital |
RECRUITING
|
| Spain | Barcelona Hosp Univ Vall D Hebron |
RECRUITING
|
| Spain | Madrid Hosp. Univ. La Paz |
RECRUITING
|
| Spain | Sevilla Hosp. Virgen Del Rocio |
RECRUITING
|
| United Kingdom | Oxford John Radcliffe Hospital |
RECRUITING
|
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