Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN)NCT03755128
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
An observational study of Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN) and Erythroblastosis, Fetal, run by Janssen Research & Development, LLC at 18 sites in 9 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN), Erythroblastosis, Fetal
- How many people
- 17 participants
- Where
- 18 sitesin 9 countries
- Study dates
- 16 Jan 2019to 22 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Participants must have an obstetrical history of severe fetal anemia, hydrops, or stillbirth related to hemolytic disease of the fetus and newborn, have alloantibody titers for anti-D ≥32 or anti-Kell titers ≥4, and be currently pregnant with an antigen-positive fetus. Eligible women may enter the study at any time during the current pregnancy prior to delivery.
Pregnant female participants must be ≥18 years of age with an estimated Gestational Age of ≥ 8 weeks; not currently pregnant with multiples (twins or more); and no other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participate.
Trial locations and contacts
18 sites in 9 countries.
18 sites in 9 countries
United States5 sites
University of Cincinnati
Cincinnati, Ohio, 45267
Columbia University Medical Center
New York, New York, 10032
UPMC
Pittsburgh, Pennsylvania, 15213
Oregon Health and Science University
Portland, Oregon, 97239
University of Utah
Salt Lake City, Utah, 84132
Canada3 sites
Centre Hospitalier Sainte Justine
Montreal, Quebec, H3T 1C5
Mount Sinai Hospital
Toronto, Ontario, M5G1X5
The University of British Columbia
Vancouver, British Columbia, V6H 3N1
Australia2 sites
Liverpool Hospital
Liverpool, 2170
The Royal Women's Hospital
Parkville, 3052
Spain2 sites
Hosp Clinic de Barcelona
Barcelona, 08028
Hosp. Univ. San Cecilio
Granada, 18016
United Kingdom2 sites
Queen Elizabeth Hospital
Edgbaston, B15 2TG
University College London Hospitals NHSFT
London, WC1E 6DB
Germany1 site
Justus-Liebig-Universität Gießen, Kinderherzzentrum
Giessen, 35392
About this study
Official title: A Multicenter, Prospective Observational 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
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).
Read the detailed description
The outcomes of interest will be assessed from the information collected on the standard of care treatment for EOS-HDFN in pregnant women and their offspring from current pregnancy.
- Conditions
- Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN), Erythroblastosis, Fetal
- Being tested
- No intervention
- Keywords
- Hemolytic disease of the fetus and newborn (HDFN), Erythroblastosis, Fetal, Early onset severe hemolytic disease of the fetus and newborn (EOS-HDFN), M281, Pregnant Women
- Medical subject headings
- Erythroblastosis, Fetal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No investigational drugs will be administered as part of the study
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women and their offspring from current pregnancy | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Live Birth at or After Gestational Age (GA) Week 32 Without Intrauterine Transfusion (IUT)
Measured: GA Week 32 through GA Week 37
Secondary outcomes (10)
Percentage of Participants With Live Birth
Measured: Up to approximately GA Week 37
Percentage of Participants at GA Week 24 Without an IUT
Measured: Week 24
GA at First IUT
Measured: Up to approximately GA Week 37
Number of IUTs Required
Measured: Up to approximately GA Week 37
Percentage of Participants With Fetal Hydrops
Measured: Post-Birth through Age 3 Months
Percentage of Neonates Requiring Phototherapy
Measured: Post-Birth through Age 3 Months
Percentage of Neonates Requiring Exchange Transfusions
Measured: Post-Birth through Age 3 Months
Number of days of phototherapy required by neonate
Measured: Post-Birth through Age 3 Months
Percentage of Neonates Requiring Simple Transfusions in the First 3 Months of Life
Measured: Post-Birth through Age 3 Months
Number of Simple Transfusions Required by Neonate in the First 3 Months of Life
Measured: Post-Birth through Age 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start16 Jan 2019
- Primary completion22 Sep 2023
- Study completion22 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN)Studies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755128
- Sponsor's protocol ID
- CR109067
- Other IDs
- MOM-M281-103
- Status last verified
- Sep 2025
- First submitted
- 26 Nov 2018
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Publications
Oepkes D, Moise KJ Jr, Lopriore E, Tiblad E, Verweij EJTJ, Windrim R, Pandya P, Silver RM, Emery SP, Smoleniec J, Ocon-Hernandez O, Morris RK, Miller RS, Streisand JB, Harrison DD, Smith V, Schwartz LB, Tjoa ML, Ling LE, Saeed-Khawaja S, Komatsu Y. Characterization of the clinical course of early-onset severe hemolytic disease of the fetus and newborn. Pregnancy (Hoboken). 2026 Jul 12;2(4):e70352. doi: 10.1002/pmf2.70352. eCollection 2026 Jul.
PubMed 42819096
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Observational 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
- ClinicalTrials.gov ID
- NCT03755128
- Acronym / sponsor ID
- CR109067
- Conditions
- Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN), Erythroblastosis, Fetal
- Keywords
- Hemolytic disease of the fetus and newborn (HDFN), Erythroblastosis, Fetal, Early onset severe hemolytic disease of the fetus and newborn (EOS-HDFN), M281, Pregnant Women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The outcomes of interest will be assessed from the information collected on the standard of care treatment for EOS-HDFN in pregnant women and their offspring from current pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women and their offspring from current pregnancy | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants must have an obstetrical history of severe fetal anemia, hydrops, or stillbirth related to hemolytic disease of the fetus and newborn, have alloantibody titers for anti-D ≥32 or anti-Kell titers ≥4, and be currently pregnant with an antigen-positive fetus. Eligible women may enter the study at any time during the current pregnancy prior to delivery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo investigational drugs will be administered as part of the study | Other | Pregnant women and their offspring from current pregnancy |
Primary outcome
Percentage of Participants With Live Birth at or After Gestational Age (GA) Week 32 Without Intrauterine Transfusion (IUT)
Time frame: GA Week 32 through GA Week 37
10 secondary outcomes
Percentage of Participants With Live Birth
Time frame: Up to approximately GA Week 37
Percentage of Participants at GA Week 24 Without an IUT
Time frame: Week 24
GA at First IUT
Time frame: Up to approximately GA Week 37
Number of IUTs Required
Time frame: Up to approximately GA Week 37
Percentage of Participants With Fetal Hydrops
Time frame: Post-Birth through Age 3 Months
Percentage of Neonates Requiring Phototherapy
Time frame: Post-Birth through Age 3 Months
Percentage of Neonates Requiring Exchange Transfusions
Time frame: Post-Birth through Age 3 Months
Number of days of phototherapy required by neonate
Time frame: Post-Birth through Age 3 Months
Percentage of Neonates Requiring Simple Transfusions in the First 3 Months of Life
Time frame: Post-Birth through Age 3 Months
Number of Simple Transfusions Required by Neonate in the First 3 Months of Life
Time frame: Post-Birth through Age 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Derived from this study: PubMed 42819096Oepkes D, Moise KJ Jr, Lopriore E, Tiblad E, Verweij EJTJ, Windrim R, Pandya P, Silver RM, Emery SP, Smoleniec J, Ocon-Hernandez O, Morris RK, Miller RS, Streisand JB, Harrison DD, Smith V, Schwartz LB, Tjoa ML, Ling LE, Saeed-Khawaja S, Komatsu Y. Characterization of the clinical course of early-onset severe hemolytic disease of the fetus and newborn. Pregnancy (Hoboken). 2026 Jul 12;2(4):e70352. doi: 10.1002/pmf2.70352. eCollection 2026 Jul.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
18 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN) and Erythroblastosis, Fetal, run by Janssen Research & Development, LLC at 18 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Canada, Australia, Spain, United Kingdom and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Live Birth at or After Gestational Age (GA) Week 32 Without Intrauterine Transfusion (IUT) (time frame: GA Week 32 through GA Week 37). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03755128, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.