Nipocalimab for high-risk pregnancy blood disease
Treatments studied
Part of Blood & lymphatic, Immune system & allergy, Women’s health & pregnancy clinical trials.
This Phase 3 trial tests nipocalimab (an antibody medicine) to help prevent severe blood breakdown in a baby when a parent has certain blood antibodies. It enrolls people who previously had severe hemolytic disease in a past pregnancy and who are currently early in pregnancy with the same risk antibodies.
Summary written for real people, not researchers, by Clin2.
Who can take part
- Be pregnant between 13 weeks 0 days and 18 weeks 6 days at the time of randomization
- In a past pregnancy, you had severe hemolytic disease in the fetus/newborn (such as fetal anemia, fluid around the baby, or needed at least one transfusion through the umbilical cord)
- In this pregnancy, blood tests show you have high-risk antibodies (RhD, Rhc, RhE, or RhC, or anti-Kell) above the study cutoff
- A special noninvasive test (fetal DNA from your blood) confirms the baby carries the target blood type linked to your antibodies
- Your screening blood and organ tests are within allowed ranges (including liver, kidney, and certain immunity levels), and you are medically stable
- You are not pregnant with twins or more
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
Similar studies
Other trials that look related to this one.
This study tracks pregnancies affected by hemolytic disease of the fetus and newborn (HDFN). It collects information to better understand the condition and improve care. You may join if you are pregnant with a history of a prior affected pregnancy and have a current antibody that could harm your baby.
This trial tests a new medicine, nipocalimab, for adults with moderate to severe lupus. It aims to see if the drug can help control lupus symptoms and reduce disease activity.
This study tests a medicine called nipocalimab for pregnant women whose babies are at risk of a bleeding condition called FNAIT. The medicine may help prevent low platelet counts and serious bleeding in the newborn.
This study tests a new medicine called nipocalimab compared to standard IVIG treatment for pregnant women who are at risk of a serious condition where the mother's antibodies attack the baby's platelets (FNAIT). The goal is to see if nipocalimab can prevent complications like bleeding in the baby.
This trial tests how much of the drug nipocalimab gets into breast milk. It is for healthy women who are currently breastfeeding their baby.
This study tests a new DNA-based method to determine a baby's blood type before birth, which helps doctors manage pregnancies at risk for hemolytic disease of the fetus and newborn (HDFN). It aims to improve care for mothers with blood type incompatibility.
Hear when a new Hemolytic Disease of the Fetus and Newborn trial opens
We’ll email you when one opens — at most once a week, no account needed, unsubscribe anytime.