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A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
NCT06533098 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06533098
The ClinicalTrials.gov registry entry for NCT06533098 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06533098 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, Alabama, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06533098?
The interventions under investigation include: Prednisone (DRUG), Nipocalimab (DRUG), Intravenous immunoglobulins (IVIG) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06533098?
This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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