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

• Conditions: Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN); Erythroblastosis, Fetal
• Interventions: Other: No intervention

• Registration Number: NCT03755128
• Lead Sponsor: Janssen Research & Development, LLC

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).

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 Timeline

• Study First Submitted: 2018-11-26
• Study First Submitted QC: 2018-11-26
• Study First Posted: 2018-11-27
• Study Start: 2019-01-16
• Primary Completion: 2023-09-22
• Study Completion: 2023-09-22
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 17

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women and their offspring from current pregnancy	No intervention	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of IUTs Required	Up to approximately GA Week 37
Percentage of Participants With Live Birth	Up to approximately GA Week 37
Number of days of phototherapy required by neonate	Post-Birth through Age 3 Months
Number of Simple Transfusions Required by Neonate in the First 3 Months of Life	Post-Birth through Age 3 Months
Percentage of Participants at GA Week 24 Without an IUT	Week 24
GA at First IUT	Up to approximately GA Week 37
Percentage of Neonates Requiring Exchange Transfusions	Post-Birth through Age 3 Months
Percentage of Participants With Fetal Hydrops	Post-Birth through Age 3 Months
Percentage of Neonates Requiring Phototherapy	Post-Birth through Age 3 Months
Percentage of Neonates Requiring Simple Transfusions in the First 3 Months of Life	Post-Birth through Age 3 Months

Trial Locations

Locations (18)

Hosp. Univ. San Cecilio; 🇪🇸 Granada, Spain

Universitair Ziekenhuis Leuven; 🇧🇪 Leuven, Belgium

University College London Hospitals NHSFT; 🇬🇧 London, United Kingdom

Liverpool Hospital; 🇦🇺 Liverpool, Australia

Karolinska Universitetssjukhuset, Huddinge; 🇸🇪 Stockholm, Sweden

Justus-Liebig-Universität Gießen, Kinderherzzentrum; 🇩🇪 Giessen, Germany

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Centre Hospitalier Sainte Justine; 🇨🇦 Montreal, Quebec, Canada

The Royal Women's Hospital; 🇦🇺 Parkville, Australia

Hosp. Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada

Queen Elizabeth Hospital; 🇬🇧 Edgbaston, United Kingdom

The University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada