Actively Recruiting
A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
50
Participants Needed
24
Research Sites
251 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the efficacy and safety of nipocalimab in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).
CONDITIONS
Official Title
A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant with an estimated gestational age between 13 and 18 weeks at the first visit
- History of at least one prior pregnancy affected by fetal and neonatal alloimmune thrombocytopenia (FNAIT) confirmed by medical records
- Current pregnancy with maternal anti-HPA-1a and/or anti-HPA-5b antibodies and positive fetal HPA-1a and/or HPA-5b genotype confirmed by fetal DNA in maternal blood
- Stable health status based on physical exam, medical history, vital signs, ECG, and lab tests at screening
- Willing to avoid participation in other investigational therapy studies until last follow-up visit for both mother and baby
You will not qualify if you...
- Currently pregnant with twins or more (multiple gestations)
- History of severe preeclampsia in a previous pregnancy
- History of heart attack, unstable ischemic heart disease, or stroke
- Known allergies or intolerance to nipocalimab, intravenous immunoglobulin (IVIG), or prednisone
- Confirmed or suspected immunodeficiency syndrome or family history of congenital or hereditary immunodeficiency unless confirmed absent in participant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205
Actively Recruiting
2
UC Davis School of Medicine
Sacramento, California, United States, 95817
Actively Recruiting
3
Childrens Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Advocate Children's Hospital
Park Ridge, Illinois, United States, 60068
Actively Recruiting
5
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
6
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
7
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Actively Recruiting
8
Oregon Health And Science University
Portland, Oregon, United States, 97239
Actively Recruiting
9
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
10
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Actively Recruiting
11
Medizinische Universitaet Graz
Graz, Austria, 8036
Actively Recruiting
12
Medical University Vienna
Vienna, Austria, 1090
Actively Recruiting
13
Universitaetsklinikum Giessen und Marburg GmbH
Giessen, Germany, 35392
Actively Recruiting
14
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
15
Universitatsklinikum Jena
Jena, Germany, 07747
Actively Recruiting
16
Universitaetsklinikum Tuebingen
Tübingen, Germany, 72076
Actively Recruiting
17
Leiden University Medical Center
Leiden, Netherlands, 2333 ZA
Actively Recruiting
18
Instytut Centrum Zdrowia Matki Polki
Lodz, Poland, 93 338
Actively Recruiting
19
Instytut Matki i Dziecka
Warsaw, Poland, 01 211
Actively Recruiting
20
Panstwowy Instytut Medyczny MSWiA w Warszawie
Warsaw, Poland, 02 507
Actively Recruiting
21
Birmingham Women's Hospital
Birmingham, United Kingdom, B15 2TG
Actively Recruiting
22
Liverpool Women's NHS Foundation Trust - Liverpool Women's Hospital
Liverpool, United Kingdom, L8 7SS
Actively Recruiting
23
Queen Charlotte's and Chelsea Hospital
London, United Kingdom, W12 0HS
Actively Recruiting
24
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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