NCT03755128

Brief 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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
9 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 16, 2019

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2023

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

4.7 years

First QC Date

November 26, 2018

Last Update Submit

September 11, 2025

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, FetalEarly onset severe hemolytic disease of the fetus and newborn (EOS-HDFN)M281Pregnant Women

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Live Birth at or After Gestational Age (GA) Week 32 Without Intrauterine Transfusion (IUT)

    GA Week 32 through GA Week 37

Secondary Outcomes (10)

  • Percentage of Participants With Live Birth

    Up to approximately GA Week 37

  • Percentage of Participants at GA Week 24 Without an IUT

    Week 24

  • GA at First IUT

    Up to approximately GA Week 37

  • Number of IUTs Required

    Up to approximately GA Week 37

  • Percentage of Participants With Fetal Hydrops

    Post-Birth through Age 3 Months

  • +5 more secondary outcomes

Study Arms (1)

Pregnant women and their offspring from current pregnancy

Other: No intervention

Interventions

No interventionOTHER

No investigational drugs will be administered as part of the study

Pregnant women and their offspring from current pregnancy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (18)

Columbia University Medical Center

New York, New York, 10032, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Liverpool Hospital

Liverpool, 2170, Australia

Location

The Royal Women's Hospital

Parkville, 3052, Australia

Location

Universitair Ziekenhuis Leuven

Leuven, 3000, Belgium

Location

The University of British Columbia

Vancouver, British Columbia, V6H 3N1, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Centre Hospitalier Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Justus-Liebig-Universität Gießen, Kinderherzzentrum

Giessen, 35392, Germany

Location

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

Location

Hosp Clinic de Barcelona

Barcelona, 08028, Spain

Location

Hosp. Univ. San Cecilio

Granada, 18016, Spain

Location

Karolinska Universitetssjukhuset Huddinge

Stockholm, SE-141 86, Sweden

Location

Queen Elizabeth Hospital

Edgbaston, B15 2TG, United Kingdom

Location

University College London Hospitals NHSFT

London, WC1E 6DB, United Kingdom

Location

MeSH Terms

Conditions

Erythroblastosis, Fetal

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHematologic DiseasesHemic and Lymphatic DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesImmune System Diseases

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2018

First Posted

November 27, 2018

Study Start

January 16, 2019

Primary Completion

September 22, 2023

Study Completion

September 22, 2023

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations

US(5)CA(3)GB(2)BE(1)AU(2)ES(2)SE(1)NL(1)DE(1)