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Recruiting Phase 3 Interventional

A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

ClinicalTrials.gov ID: NCT06533098

Public ClinicalTrials.gov record NCT06533098. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 9:34 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Multicenter, Open-Label, Randomized Study of Nipocalimab or IVIG in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT06533098
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Enrollment
50 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 45 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 9, 2025
Primary completion
Dec 14, 2027
Completion
Dec 10, 2029
Last update posted
Aug 27, 2026

2025 – 2029

United States locations

U.S. sites
13
U.S. states
13
U.S. cities
13
Facility City State ZIP Site status
The University of Alabama at Birmingham Birmingham Alabama 35233 Recruiting
UC Davis School of Medicine Sacramento California 95817 Recruiting
Childrens Hospital Colorado Aurora Colorado 80045 Recruiting
Advocate Children's Hospital Park Ridge Illinois 60068 Recruiting
Riley Children s Hospital Indianapolis Indiana 46202 Suspended
University of Iowa Hospital and Clinics Iowa City Iowa 52242 Recruiting
University of Rochester Medical Center Rochester New York 14642 Recruiting
University of North Carolina at Chapel Hill Chapel Hill North Carolina 27599 Recruiting
University of Cincinnati Cincinnati Ohio 45267 Recruiting
Oregon Health And Science University Portland Oregon 97239 Recruiting
Hospital of the University of Pennsylvania Philadelphia Pennsylvania 19104 Recruiting
University of Texas Medical Branch Galveston Texas 77555 Recruiting
University of Utah Salt Lake City Utah 84108 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 15 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06533098, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 27, 2026 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06533098 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →