Who is sponsoring NCT03755128?

NCT03755128 is sponsored by Janssen Research & Development, LLC.

What drugs are being tested in NCT03755128?

Interventions in NCT03755128: No intervention.

Is NCT03755128 still recruiting?

NCT03755128 is currently completed. Last updated 12 September 2025.

Last reviewed 2025-09-12 · How we verify

NCT03755128

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Characterize the Clinical Course of Pregnant Women and Children at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn

Completed Last updated 12 September 2025

What this trial tests

trial testing No intervention in Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN) in 17 participants. Completed in 22 September 2023.

Timeline

16 January 2019

Primary endpoint
22 September 2023

22 September 2023

Quick facts

Lead sponsor	Janssen Research & Development, LLC
Status	Completed
Study type	OBSERVATIONAL
Enrollment	17
Start date	16 January 2019
Primary completion	22 September 2023
Estimated completion	22 September 2023
Sites	18 locations across Netherlands, Belgium, Sweden, United Kingdom, Germany, Canada, Australia, United States

Drugs / interventions tested

No intervention

Conditions studied

Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN) — all drugs for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN) →
Erythroblastosis, Fetal — all drugs for Erythroblastosis, Fetal →

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

18 and older, female only, with Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN) or Erythroblastosis, Fetal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary purpose of the study is to characterize the current standard of care, clinical course, and outcomes of pregnant women and their offspring at high risk for early onset severe hemolytic disease of the fetus and newborn (EOS-HDFN).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

The therapeutic age of the neonatal Fc receptor.
Pyzik M, Kozicky LK, Gandhi AK, Blumberg RS. · · 2023 · cited 166× · PMID 36726033 · DOI 10.1038/s41577-022-00821-1
Monoclonal Antibody Engineering and Design to Modulate FcRn Activities: A Comprehensive Review.
Ramdani Y, Lamamy J, Watier H, Gouilleux-Gruart V. · · 2022 · cited 32× · PMID 36077002 · DOI 10.3390/ijms23179604
Current state and potential applications of neonatal Fc receptor (FcRn) inhibitors in hematologic conditions.
Jacobs JW, Booth GS, Raza S, Clark LM, et al · · 2024 · cited 14× · PMID 39324647 · DOI 10.1002/ajh.27487
Targeting the neonatal Fc receptor (FcRn) to treat autoimmune diseases and maternal-fetal immune cytopenias.
Wyckoff SL, Hudson KE. · · 2021 · cited 7× · PMID 33650699 · DOI 10.1111/trf.16341
Research progress on neonatal Fc receptor and its application.
Hu M, Wei S, Zhou W, Wang P. · · 2021 · cited 2× · PMID 34704415 · DOI 10.3724/zdxbyxb-2021-0252
Abstracts presented at the Society of Obstetric Medicine of Australia and New Zealand (SOMANZ) 2023 Annual meeting in Adelaide, Australia, 6-8 Oct 2023
· 2024

Verify or expand the search:

Other trials of No intervention

Trials testing the same drug.

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Other Janssen Research & Development, LLC trials

Trials by the same sponsor.

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NCT07499232 — A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease · Phase 3 · not yet recruiting
NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
NCT07227025 — A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer · Phase 1, PHASE2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03755128 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Janssen Research & Development, LLC
Last refreshed: 12 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03755128.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing