Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06449651
PHASE3

A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the effectiveness of nipocalimab compared with placebo in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).

Official title: Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

39

Start Date

2024-11-11

Completion Date

2029-12-05

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

DRUG

Nipocalimab

Nipocalimab will be administered intravenously.

DRUG

Placebo

Placebo will be administered intravenously.

Locations (21)

Universitair Ziekenhuis Leuven

Leuven, Belgium

Instituto de Medicina Integral Professor Fernando Figueira

Recife, Brazil

Instituto D Or de Pesquisa e Ensino IDOR

Rio de Janeiro, Brazil

Hospital Das Clinicas Da Faculdade De Medicina Da USP

São Paulo, Brazil

CHRU Lille

Lille, France

Hopital trousseau- APHP

Paris, France

Semmelweis Egyetem

Budapest, Hungary

Sheba Medical Center

Ramat Gan, Israel

Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico

Milan, Italy

Fondazione Policlinico Universitario A Gemelli IRCCS

Rome, Italy

Haukeland University Hospital

Bergen, Norway

Oslo University Hospital HF Ulleval sykehus

Oslo, Norway

Universitetssykehuset Nord-Norge HF

Tromsø, Norway

St. Olavs Hospital

Trondheim, Norway

Univerzitna nemocnica L. Pasteura Kosice

Košice, Slovakia

Univerzitná nemocnica Martin

Martin, Slovakia

Fakultna nemocnica s poliklinikou Nove Zamky

Nové Zámky, Slovakia

Univerzitetni klinicni center Ljubljana

Ljubljana, Slovenia

Hosp. Virgen Del Rocio

Seville, Spain

Karolinska Universitetssjukhuset Huddinge

Stockholm, Sweden

Centre Hospitalier Universitaire Vaudois CHUV

Lausanne, Switzerland