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NCT06533098 · ClinicalTrials.gov registry record · Phase 3
A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
A Phase 3 study of Thrombocytopenia, Neonatal Alloimmune, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
- 20
- Study locations
NCT06533098: Recruiting Phase 3 study of Thrombocytopenia, Neonatal Alloimmune, sponsored by Janssen Research & Development.
NCT06533098 is a Phase 3 study of Thrombocytopenia, Neonatal Alloimmune that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 50 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06533098, a Phase 3 study of Thrombocytopenia, Neonatal Alloimmune, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 50 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Prednisone
- DRUG Nipocalimab
- DRUG Intravenous immunoglobulins (IVIG)
Study Locations (20)
Other
- Medizinische Universitaet Graz - Graz
- Medical University Vienna - Vienna
- Universitaetsklinikum Giessen und Marburg GmbH - Giessen
- Medizinische Hochschule Hannover - Hanover
- Universitatsklinikum Jena - Jena
- Universitaetsklinikum Tuebingen - Tübingen
- Leiden University Medical Center - Leiden
- Instytut Centrum Zdrowia Matki Polki - Lodz
- Instytut Matki i Dziecka - Warsaw
- Panstwowy Instytut Medyczny MSWiA w Warszawie - Warsaw
- Birmingham Women's Hospital - Birmingham
- Liverpool Women's NHS Foundation Trust - Liverpool Women's Hospital - Liverpool
Alabama
- The University of Alabama at Birmingham - Birmingham
California
- UC Davis School of Medicine - Sacramento
Colorado
- Childrens Hospital Colorado - Aurora
Illinois
- Advocate Children's Hospital - Park Ridge
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Ohio
- University of Cincinnati - Cincinnati
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-02-10 |
| Est. Completion | 2029-12-05 |
| Phase | Phase 3 |
What NCT06533098 shows while recruiting
NCT06533098 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Thrombocytopenia, Neonatal Alloimmune appearing as the primary indexed condition, and to 3 interventions - of which Prednisone is the first listed.
NCT06533098 names 20 study sites across 9 states, led by Other, Alabama, California.
Frequently Asked Questions
What is clinical trial NCT06533098 about?
NCT06533098 is a clinical study titled "A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)". 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).
What is the current status of trial NCT06533098?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2025-02-10. Estimated completion is 2029-12-05.
What conditions does trial NCT06533098 study?
This clinical trial studies the following conditions: Thrombocytopenia, Neonatal Alloimmune.
What interventions are being tested in trial NCT06533098?
The interventions under investigation include: Prednisone (DRUG), Nipocalimab (DRUG), Intravenous immunoglobulins (IVIG) (DRUG).
Who is sponsoring clinical trial NCT06533098?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06533098 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Illinois, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06533098's enrollment target sits among peer trials
50 1845th of 2000 higher than 141 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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