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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: Recruiting Phase 3 study of Hemolytic Disease of the Fetus and Newborn, sponsored by Janssen Research & Development.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percentage of pregnancies that did not result in fetal loss, IUT, hydrops fetalis, or neonatal death (during the neonatal period) will be reported. Hydrops fetalis is defined as the presence of greater than or equal to(\>=)2 abnormal fluid collections in the fetus or neonate, such as ascites, pleural effusions, pericardial effusion, and generalized skin edema (skin thickness greater (\>)5 millimeter \[mm\]). PMA is the time elapsed between the first day of the last menstrual period and birth (ge
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 |
What NCT05912517 shows while recruiting
NCT05912517 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
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 names 20 study sites across 15 states, led by 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.
Learn More About Clinical Trials
Similar trials for Hemolytic Disease of the Fetus and Newborn
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05912517's enrollment target sits among peer trials
120 1620th of 2000 higher than 361 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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