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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03755128




Registration number
NCT03755128
Ethics application status
Date submitted
26/11/2018
Date registered
27/11/2018
Date last updated
23/04/2024

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
MOM-M281-103
Secondary ID [2] 0 0
CR109067
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN) 0 0
Erythroblastosis, Fetal 0 0
Condition category
Condition code
Blood 0 0 0 0
Haematological diseases
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - No intervention

Pregnant women and their offspring from current pregnancy -


Other interventions: No intervention
No investigational drugs will be administered as part of the study
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Live Birth at or After Gestational Age (GA) Week 32 Without Intrauterine Transfusion (IUT)
Timepoint [1] 0 0
GA Week 32 through GA Week 37
Secondary outcome [1] 0 0
Percentage of Participants With Live Birth
Timepoint [1] 0 0
Up to approximately GA Week 37
Secondary outcome [2] 0 0
Percentage of Participants at GA Week 24 Without an IUT
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
GA at First IUT
Timepoint [3] 0 0
Up to approximately GA Week 37
Secondary outcome [4] 0 0
Number of IUTs Required
Timepoint [4] 0 0
Up to approximately GA Week 37
Secondary outcome [5] 0 0
Percentage of Participants With Fetal Hydrops
Timepoint [5] 0 0
Post-Birth through Age 3 Months
Secondary outcome [6] 0 0
Percentage of Neonates Requiring Phototherapy
Timepoint [6] 0 0
Post-Birth through Age 3 Months
Secondary outcome [7] 0 0
Percentage of Neonates Requiring Exchange Transfusions
Timepoint [7] 0 0
Post-Birth through Age 3 Months
Secondary outcome [8] 0 0
Number of days of phototherapy required by neonate
Timepoint [8] 0 0
Post-Birth through Age 3 Months
Secondary outcome [9] 0 0
Percentage of Neonates Requiring Simple Transfusions in the First 3 Months of Life
Timepoint [9] 0 0
Post-Birth through Age 3 Months
Secondary outcome [10] 0 0
Number of Simple Transfusions Required by Neonate in the First 3 Months of Life
Timepoint [10] 0 0
Post-Birth through Age 3 Months

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/09/2023
Sample size
Target
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
Ohio
Country [3] 0 0
United States of America
State/province [3] 0 0
Oregon
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Utah
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Canada
State/province [7] 0 0
British Columbia
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
Germany
State/province [10] 0 0
Giessen
Country [11] 0 0
Netherlands
State/province [11] 0 0
Leiden
Country [12] 0 0
Spain
State/province [12] 0 0
Barcelona
Country [13] 0 0
Spain
State/province [13] 0 0
Granada
Country [14] 0 0
Sweden
State/province [14] 0 0
Stockholm
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Edgbaston
Country [16] 0 0
United Kingdom
State/province [16] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT03755128
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03755128