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

PHASE3RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

February 10, 2025

Primary Completion Date

December 15, 2027

Study Completion Date

December 5, 2029

Conditions
Thrombocytopenia, Neonatal Alloimmune
Interventions
DRUG

Nipocalimab

Nipocalimab will be administered intravenously.

DRUG

Intravenous immunoglobulins (IVIG)

IVIG will be administered intravenously.

DRUG

Prednisone

Prednisone will be administered orally.

Trial Locations (14)

1090

RECRUITING

Medical University Vienna, Vienna

8036

RECRUITING

Medizinische Universitaet Graz, Graz

19104

RECRUITING

Hospital of the University of Pennsylvania, Philadelphia

30625

RECRUITING

Medizinische Hochschule Hannover, Hanover

35392

RECRUITING

Universitaetsklinikum Giessen und Marburg GmbH, Giessen

72076

RECRUITING

Universitaetsklinikum Tuebingen, Tübingen

07747

RECRUITING

Universitatsklinikum Jena, Jena

93 338

RECRUITING

Instytut Centrum Zdrowia Matki Polki, Lodz

01 211

RECRUITING

Instytut Matki i Dziecka, Warsaw

02 507

RECRUITING

Panstwowy Instytut Medyczny MSWiA w Warszawie, Warsaw

B15 2TG

RECRUITING

Birmingham Women's Hospital, Birmingham

L8 7SS

RECRUITING

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

W12 0HS

RECRUITING

Queen Charlotte's and Chelsea Hospital, London

OX3 9DU

RECRUITING

John Radcliffe Hospital, Oxford

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY