80202135EBF0001_Non Interventional Outcome of pregnancies with HDFN_2
Research type
Research Study
Full title
A Historical Cohort, Multicenter Study to Characterize the Management, Clinical Course, and Outcomes of Pregnancies in Women Who Have Experienced a Pregnancy With Early Onset Severe HDFN
IRAS ID
324290
Contact name
Jason Balderson
Contact email
Sponsor organisation
Janssen Research & Development, LLC
Clinicaltrials.gov Identifier
EDMS-RIM-925766, 1.0, EDMS Number
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
This is a historical cohort, observational study designed to collect health information to gain further understanding on the management, clinical course, and risk of re-occurrence of severe haemolytic disease of the foetus and newborn (HDFN) in women who have had pregnancies with offspring affected by early onset severe (EOS)-HDFN.
Data will be used for external control comparisons to evaluate the data in the sponsor’s MOM-M281-003 study to evaluate nipocalimab when administered to pregnant women at high risk for EOS-HDFN.
HDFN may develop when a mother and her unborn baby have different blood types. The types are based on small substances (antigens) on the surface of the red blood cells.Data will be collected from the medical charts of eligible women (in the timeframe from 2006 to 2019 at the selected sites) who have had at least one pregnancy affected by EOS-HDFN and who then had at least one subsequent antigen-positive pregnancy. The target is approximately 50 women.
The study consists of collecting health information already available in the participant’s medical records retrospectively. The study itself has no impact on their care. Participants will not be required to visit the study site.
Maternal and foetal data will be obtained from the gestational period through birth. If available, neonatal data will be collected up to 12 weeks of age.
REC name
London - Riverside Research Ethics Committee
REC reference
23/LO/0678
Date of REC Opinion
10 Aug 2023
REC opinion
Favourable Opinion