Clinical trial NCT03755128: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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, Fetal
Early onset severe hemolytic disease of the fetus and newborn (EOS-HDFN)
M281
Pregnant Women
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-11-27
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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.

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.

Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Live Birth at or After Gestational Age (GA) Week 32 Without Intrauterine Transfusion (IUT)
timeFrame: GA Week 32 through GA Week 37
Secondary outcomes:
measure: Percentage of Participants With Live Birth
timeFrame: Up to approximately GA Week 37
measure: Percentage of Participants at GA Week 24 Without an IUT
timeFrame: Week 24
measure: GA at First IUT
timeFrame: Up to approximately GA Week 37
measure: Number of IUTs Required
timeFrame: Up to approximately GA Week 37
measure: Percentage of Participants With Fetal Hydrops
timeFrame: Post-Birth through Age 3 Months
measure: Percentage of Neonates Requiring Phototherapy
timeFrame: Post-Birth through Age 3 Months
measure: Percentage of Neonates Requiring Exchange Transfusions
timeFrame: Post-Birth through Age 3 Months
measure: Number of days of phototherapy required by neonate
timeFrame: Post-Birth through Age 3 Months
measure: Percentage of Neonates Requiring Simple Transfusions in the First 3 Months of Life
timeFrame: Post-Birth through Age 3 Months
measure: Number of Simple Transfusions Required by Neonate in the First 3 Months of Life
timeFrame: Post-Birth through Age 3 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Liverpool
country: Australia
facility: Liverpool Hospital
city: Parkville
country: Australia
facility: The Royal Women's Hospital
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Vancouver
country: Canada
facility: The University of British Columbia
state: British Columbia
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier Sainte Justine
state: Quebec
city: Giessen
country: Germany
facility: Justus-Liebig-Universität Gießen, Kinderherzzentrum
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Granada
country: Spain
facility: Hosp. Univ. San Cecilio
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Huddinge
city: Edgbaston
country: United Kingdom
facility: Queen Elizabeth Hospital
city: London
country: United Kingdom
facility: University College London Hospitals NHSFT
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: