Clinical Trials in Italy / NCT06449651
Recruiting
Phase 3
A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
NCT06449651 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Thrombocytopenia, Neonatal Alloimmune
Investigational drug(s) / intervention(s)
Nipocalimab →Placebo
Nipocalimab: Nipocalimab will be administered intravenously.
Placebo: Placebo will be administered intravenously.
Study 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
Inclusion Criteria:
* 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 a clinical review of the 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
Exclusion Criteria:
* Currently pregnant with multiple gestations (twins or more)
* History of severe preeclampsia in a previous pregnancy
* History of myocardial infarction, unstable ischemic heart disease, or stroke
* Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients (refer to the Investigator Brochure (IB))
* Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
Primary outcome measure(s)
- Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L — Up to 1 week post birth
Outcome of fetus/neonate death or adjudicated severe bleeding up to the first week post birth or platelet count \<30\*10\^9/L will be reported.
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| Universitair Ziekenhuis Leuven | Leuven | Belgium | Recruiting |
| Instituto de Medicina Integral Professor Fernando Figueira | Recife | Brazil | Completed |
| IDOR - Regional Rio de Janeiro | Rio de Janeiro | Brazil | Completed |
| Hospital Das Clinicas Da Faculdade De Medicina Da USP | São Paulo | Brazil | Completed |
| CHRU Lille | Lille | France | Recruiting |
| Hopital trousseau- APHP | Paris | France | Recruiting |
| Semmelweis Egyetem | Budapest | Hungary | Recruiting |
| Sheba Medical Center | Ramat Gan | Israel | Completed |
| Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico | Milan | Italy | Recruiting |
| Fondazione Policlinico Universitario A Gemelli IRCCS | Rome | Italy | Recruiting |
| Haukeland University Hospital | Bergen | Norway | Recruiting |
| Oslo University Hospital HF Ulleval sykehus | Oslo | Norway | Recruiting |
| Universitetssykehuset Nord-Norge HF | Tromsø | Norway | Recruiting |
| St. Olavs Hospital | Trondheim | Norway | Recruiting |
| Univerzitna nemocnica L. Pasteura Kosice | Košice | Slovakia | Recruiting |
| Univerzitná nemocnica Martin | Martin | Slovakia | Recruiting |
| Fakultna nemocnica s poliklinikou Nove Zamky | Nové Zámky | Slovakia | Recruiting |
| Univerzitetni klinicni center Ljubljana | Ljubljana | Slovenia | Recruiting |
| Hosp. Virgen Del Rocio | Seville | Spain | Completed |
| Karolinska Universitetssjukhuset Huddinge | Stockholm | Sweden | Recruiting |
| Centre Hospitalier Universitaire Vaudois CHUV | Lausanne | Switzerland | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06449651 on ClinicalTrials.gov ↗ ← All trials in Italy