RecruitingPhase 3NCT06533098

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

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

Sponsor

Janssen Research & Development, LLC

Enrollment

50 participants

Start Date

Feb 10, 2025

Study Type

INTERVENTIONAL

Conditions

Thrombocytopenia, Neonatal Alloimmune

Summary

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).

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Intravenous immunoglobulins (IVIG), a drug called Nipocalimab, and others for people with thrombocytopenia, neonatal alloimmune. The study is currently recruiting participants at 25 locations. People eligible for this study include women aged 18 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNipocalimab

Nipocalimab will be administered intravenously.

DRUGIntravenous immunoglobulins (IVIG)

IVIG will be administered intravenously.

DRUGPrednisone

Prednisone will be administered orally.

Locations(26)

The University of Alabama at Birmingham

Birmingham, Alabama, United States

UC Davis School of Medicine

Sacramento, California, United States

Childrens Hospital Colorado

Aurora, Colorado, United States

Advocate Children's Hospital

Park Ridge, Illinois, United States

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

University of Rochester Medical Center

Rochester, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Oregon Health And Science University

Portland, Oregon, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Texas Medical Branch

Galveston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Medizinische Universitaet Graz

Graz, Austria

Medical University Vienna

Vienna, Austria

Universitaetsklinikum Giessen und Marburg GmbH

Giessen, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Universitatsklinikum Jena

Jena, Germany

Universitaetsklinikum Tuebingen

Tübingen, Germany

Leiden University Medical Center

Leiden, Netherlands

Instytut Centrum Zdrowia Matki Polki

Lodz, Poland

Instytut Matki i Dziecka

Warsaw, Poland

Panstwowy Instytut Medyczny MSWiA w Warszawie

Warsaw, Poland

Birmingham Women's Hospital

Birmingham, United Kingdom

Liverpool Women's NHS Foundation Trust - Liverpool Women's Hospital

Liverpool, United Kingdom

Queen Charlotte's and Chelsea Hospital

London, United Kingdom

John Radcliffe Hospital

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06533098

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