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

Erythroblastosis, Fetal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03755128
• Other study ID #: CR109067
• Secondary ID: MOM-M281-103
• Status: Completed
• Start date: January 16, 2019
• Est. completion date: September 22, 2023

Study information

• Verified date: April 2024
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 22, 2023
• Est. primary completion date: September 22, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disease Progression
• Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN)
• Erythroblastosis, Fetal
• Hemolysis

Intervention

Other:
• No intervention
No investigational drugs will be administered as part of the study

Locations

Country	Name	City	State
Australia	Liverpool Hospital	Liverpool
Australia	The Royal Women's Hospital	Parkville
Belgium	Universitair Ziekenhuis Leuven	Leuven
Canada	Centre Hospitalier Sainte Justine	Montreal	Quebec
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	The University of British Columbia	Vancouver	British Columbia
Germany	Justus-Liebig-Universität Gießen, Kinderherzzentrum	Giessen
Netherlands	Leiden University Medical Center	Leiden
Spain	Hosp. Clinic de Barcelona	Barcelona
Spain	Hosp. Univ. San Cecilio	Granada
Sweden	Karolinska Universitetssjukhuset, Huddinge	Stockholm
United Kingdom	Queen Elizabeth Hospital	Edgbaston
United Kingdom	University College London Hospitals NHSFT	London
United States	University of Cincinnati	Cincinnati	Ohio
United States	Columbia University Medical Center	New York	New York
United States	UPMC	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Germany,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

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