Clinical trials: HDFN
HDFN
Establish a Non-invasive Prenatal Genotyping and Extraction Technology to Diagnose and Treat the HDN.
To establish a genotyping and extraction technology of non invasive prenatal diagnosis for fetal blood group genotype from cell-free fetal DNA in peripheral blood of pregnant women.
- Trial name
- NCT02969174
- Testing
- zimin Lu,Guo Sa
- Sponsor
- Shanghai Tongji Hospital, Tongji University School of Medicine
s100b, Hypoxia-Ischemia, Brain
Cord Blood S100B Protein Levels in Neonates Following Intrauterine Transfusions for HDFN-Associated Fetal Anemia
levated levels of S100B protein are a well-established marker of central nervous system (CNS) damage. Fetal anemia resulting from hemolytic disease of the fetus and newborn (HDFN) often necessitates intrauterine transfusions…
- Conditions
- s100b, Hypoxia-Ischemia, Brain, Hemolytic Disease of the Fetus and Newborn, Fetal Anemia
- Trial name
- NCT06984445
- Testing
- Cord blood S100B protein level prior to IUT, Umbilical cord blood gas analysis prior to IUT, Fetal blood count evaluation prior to IUT
- Where
- Poland
- Volunteers
- 180 people
- Sponsor
- Institute of Mother and Child, Warsaw, Poland
Red Blood Cell Alloimmunization in Pregnancy, HDFN
Prenatal Blood Typing With Next Generation Sequencing (NGS) - an Implementation Study in HDFN (PREFAB)
Determination of Fetal Blood Group by Next-Generation Sequencing - A Clinical Study in Pregnancies with Maternal Alloantibodies Directed Against Fetal Blood Cells (Alloimmunization During Pregnancy) Maternal antibodies can cross…
- Conditions
- Red Blood Cell Alloimmunization in Pregnancy, HDFN, Next Generation Sequencing (NGS)
- Trial name
- PREFAB (NCT07715214)
- Testing
- NGS analysis for fetal red cell blood type in maternal plasma
- Volunteers
- 750 people
- Sponsor
- Karolinska University Hospital
Hemolytic Disease of the Fetus and Newborn
A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
The purpose of this study is to evaluate the safety in mother and neonate/infant of M281 administered to pregnant women who are at high risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN).
- Trial name
- NCT03842189
- Testing
- M281
- Where
- 19 sites in United States, Australia and 7 more
- Volunteers
- 25 people
- Sponsor
- Janssen Research & Development, LLC
Erythroblastosis, Fetal, Erythroblastosis Fetalis, Rh Disease
EPO-4-Rhesus Study
Up to 80% of infants with hemolytic disease due to maternal alloimmunization, treated with IUT, require at least one top-up transfusion for late anemia during the first 3 months of life.
- Conditions
- Erythroblastosis, Fetal, Erythroblastosis Fetalis, Rh Disease, Erythroblastosis Fetalis Due to RH Antibodies, Erythroblastosis Fetalis Due to Isoimmunization
- Trial name
- EPO-4-Rhesus (NCT03104426)
- Testing
- Darbepoetin Alfa
- Where
- Netherlands
- Volunteers
- 42 people
- Sponsor
- Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN), Erythroblastosis, Fetal
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
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…
- Trial name
- NCT03755128
- Testing
- No intervention
- Where
- 18 sites in United States, Australia and 7 more
- Volunteers
- 17 people
- Sponsor
- Janssen Research & Development, LLC
Hemolytic Disease of the Fetus and Newborn
A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
The purpose of this study is to assess the effectiveness of nipocalimab when compared to placebo in decreasing the risk of fetal anemia (a condition in which a baby's red blood cell volume falls below normal levels while the baby…
- Trial name
- AZALEA (NCT05912517)
- Testing
- Nipocalimab
- Where
- 65 sites in United States, Argentina and 15 more
- Volunteers
- 120 people
- Sponsor
- Janssen Research & Development, LLC
Hemolytic Disease of the Fetus and Newborn
A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry
The purpose of this non-interventional study is to prospectively evaluate the risk of anemia (decreased red blood cells) in fetuses (baby before birth) and neonates (baby just after birth) of pregnant participants who are at risk…
- Trial name
- GERANIUM (NCT07194070)
- Testing
- Standard of Care
- Where
- 15 sites in United States, Australia and 6 more
- Volunteers
- 175 people
- Sponsor
- Janssen Research & Development, LLC