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
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:
• Pregnant and an estimated gestational age (GA; based on ultrasound dating) from Week 13 to 18 at randomization
• Has a history of greater than or equal to (\>=) 1 prior pregnancy with fetal and neonatal alloimmune thrombocytopenia (FNAIT) (including neonatal platelet count less than (\<) 150×10\^9/Liter) with none of them affected by fetal/neonatal intracranial hemorrhage (ICH) or severe hemorrhage based on medical records
• Current pregnancy with presence of maternal anti- human platelet antigen (HPA)-1a alloantibody and positive fetal HPA-1a genotype as confirmed by cell-free fetal deoxyribonucleic acid (DNA) in maternal blood
• Health status considered stable by the investigator based on physical examination, medical history, vital signs, 12-lead Electrocardiogram (ECG), and clinical laboratory tests performed at screening
• For maternal participant and neonate/infant, willing to forego participation in another clinical study of an investigational therapy until the last follow-up visit
Locations
Other Locations
Belgium
Universitair Ziekenhuis Leuven
RECRUITING
Leuven
Brazil
Instituto de Medicina Integral Professor Fernando Figueira
RECRUITING
Recife
Instituto D Or de Pesquisa e Ensino IDOR
RECRUITING
Rio De Janeiro
Hospital Das Clinicas Da Faculdade De Medicina Da USP
RECRUITING
São Paulo
France
CHRU Lille
RECRUITING
Lille
Hopital trousseau- APHP
RECRUITING
Paris
Hungary
Semmelweis Egyetem
RECRUITING
Budapest
Israel
Sheba Medical Center
RECRUITING
Ramat Gan
Italy
Fondazione Policlinico Universitario A Gemelli IRCCS
RECRUITING
Rome
Norway
Haukeland University Hospital
RECRUITING
Bergen
Oslo University Hospital HF Ulleval sykehus
RECRUITING
Oslo
Universitetssykehuset Nord-Norge HF
RECRUITING
Tromsø
St. Olavs Hospital
RECRUITING
Trondheim
Slovakia
Univerzitna nemocnica L. Pasteura Kosice
RECRUITING
Košice
Univerzitná nemocnica Martin
RECRUITING
Martin
Fakultna nemocnica s poliklinikou Nove Zamky
RECRUITING
Nové Zámky
Slovenia
Univerzitetni klinicni center Ljubljana
RECRUITING
Ljubljana
Spain
Hosp. Virgen Del Rocio
RECRUITING
Seville
Sweden
Karolinska Universitetssjukhuset Huddinge
RECRUITING
Stockholm
Switzerland
Centre Hospitalier Universitaire Vaudois CHUV
RECRUITING
Lausanne
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date:2024-11-11
Estimated Completion Date:2029-12-11
Participants
Target number of participants:39
Treatments
Active_comparator: Nipocalimab
Maternal participants will receive nipocalimab Intravenously (IV).