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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 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. The trial reports 20 study locations across 9 states.
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).
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 |
Interested in This Trial?
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, categorized as Phase 3. 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 593 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.
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