Description
Purpose
The purpose of this study is to assess the effectiveness of nipocalimab when compared to placebo (non-active medication) 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 (HDFN).
Description
(HDFN) is a rare and potentially life-threatening maternal-fetal disease that can lead to serious health complications for the baby. HDFN occurs when there is an incompatibility between the mother’s and baby’s red blood cells. The mother’s immune system responds to the incompatibility by producing antibodies that seek out the baby’s red blood cells and tries to get rid of them.
Participation in this clinical trial includes weekly intravenous (IV) infusions while visiting the trial site approximately 20 - 23 times during your pregnancy. You will be randomly assigned to receive an infusion of the investigational medication; this can be the active investigational medication or placebo. After your child’s birth, you will have three additional trial site visits over the course of six months, and your child will have six trial site visits over the course of two years.
Eligibility
Inclusion Criteria
Inclusion Criteria-including but may not be limited to:
- Female, 18 to 45 years of age, inclusive, at the time of informed consent
- History of severe HDFN in a prior pregnancy
- Agrees to receive recommended vaccinations according to local standard of care for both maternal participant and infant throughout the course of the study.
- Presence of maternal alloantibody to RhD, Kell, Rhc, RhE, or RhC antigen with titers above the critical level
- Evidence of antigen-positivity corresponding to the current maternal alloantibody (RhD, Kell, Rhc, RhE, or RhC) confirmed by non-invasive antigen cffDNA
To Participate
Please contact the Network Office of Research and Innovation at 610-402-9543.
For additional information
Study Details | A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN) | ClinicalTrials.gov
