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NCT05912517 · ClinicalTrials.gov registry record · Phase 3
A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
A Phase 3 study of Hemolytic Disease of the Fetus and Newborn, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT05912517 is a Phase 3 study of Hemolytic Disease of the Fetus and Newborn that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 120 participants. The trial reports 20 study locations across 15 states.
The verdict
NCT05912517, a Phase 3 study of Hemolytic Disease of the Fetus and Newborn, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the effectiveness of nipocalimab when compared to placebo in decreasing the risk of fetal anemia (a condition in which a baby's red blood cell volume falls below normal levels while the baby is developing in the womb) with live neonates in pregnant participants at risk for severe hemolytic disease of the fetus and newborn.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Nipocalimab
Study Locations (20)
California
- University of California at San Diego - La Jolla
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- UC Davis School of Medicine - Sacramento
Other
- Hospital Italiano de Buenos Aires - Buenos Aires
- Hospital Privado Universitario De Cordoba - Córdoba
- Mater Hospital Brisbane - South Brisbane
Texas
- University of Texas Dell Medical School Department of Women's Health - Austin
- University Of Texas Medical Branch At Galveston - Galveston
Colorado
- Childrens Hospital Colorado - Aurora
Illinois
- Advocate Children's Hospital - Park Ridge
Indiana
- Riley Children s Hospital - Indianapolis
Kentucky
- University of Kentucky Medical Center - Lexington
Maryland
- Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-12-20 |
| Est. Completion | 2029-07-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05912517
The ClinicalTrials.gov registry entry for NCT05912517 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 120 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 Hemolytic Disease of the Fetus and Newborn appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05912517 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Other, Texas.
Frequently Asked Questions
What is clinical trial NCT05912517 about?
NCT05912517 is a clinical study titled "A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)". The purpose of this study is to assess the effectiveness of nipocalimab when compared to placebo in decreasing the risk of fetal anemia (a condition in which a baby's red blood cell volume falls below normal levels while the baby is developing in the womb) with live neonates in pregnant participants...
What is the current status of trial NCT05912517?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2023-12-20. Estimated completion is 2029-07-10.
What conditions does trial NCT05912517 study?
This clinical trial studies the following conditions: Hemolytic Disease of the Fetus and Newborn.
What interventions are being tested in trial NCT05912517?
The interventions under investigation include: Placebo (DRUG), Nipocalimab (DRUG).
Who is sponsoring clinical trial NCT05912517?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05912517 being conducted?
This trial has 20 study locations across California, Colorado, Illinois, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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