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Current Research and Clinical Trials

It can be difficult to keep up with the current research programs and clinical trials accepting new patients. This page is all about the current clinical trials for women with alloimmunization and children with HDFN. If you have a research program or trial that you would like added to this list, please contact us.

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

Enrollment:   Open

Study Type:   Observational

Country:   Multiple

Criteria:

"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. 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."

Outcome Measures:

  • ● Percentage of participants with a live birth at or after 32 weeks without IUT.
  • ● Percentage of Participants With Live Birth [ Time Frame: Up to approximately GA Week 37 ]
  • ● Percentage of Participants at GA Week 24 Without an IUT [ Time Frame: Week 24 ]
  • ● GA at First IUT [ Time Frame: Up to approximately GA Week 37 ]
  • ● Number of IUTs Required [ Time Frame: Up to approximately GA Week 37 ]
  • ● Percentage of Participants With Fetal Hydrops [ Time Frame: Post-Birth through Age 3 Months ]
  • ● Percentage of Neonates Requiring Phototherapy [ Time Frame: Post-Birth through Age 3 Months]
  • ● Percentage of Neonates Requiring Exchange Transfusions [ Time Frame: Post-Birth through Age 3 Months ]
  • ● Number of days of phototherapy required by neonate [ Time Frame: Post-Birth through Age 3 Months ]
  • ● Percentage of Neonates Requiring Simple Transfusions in the First 3 Months of Life [ Time Frame: Post-Birth through Age 3 Months ]
  • ● Number of Simple Transfusions Required by Neonate in the First 3 Months of Life [ Time Frame: Post-Birth through Age 3 Months ]

Links:

https://clinicaltrials.gov/ct2/show/NCT03755128

Enrollment:   Open

Study Type:   Interventional

Country:   Multiple

Criteria:

"Pregnant female participants must be ≥18 years of age with an estimated gestational age of 8 to 13 weeks at enrollment; a previous pregnancy with a gestation that included at least one condition [severe fetal anemia, fetal hydrops (ascites), or stillbirth with fetal or placental pathology indicative of Hemolytic Disease of the Fetus and Newborn] at ≤24 weeks gestation; not currently pregnant with multiples (twins or more), up to date on required immunizations; and no other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participate."

Outcome Measures:

  • ● Number of Participants With Adverse Events (AEs) [ Time Frame: From signing of informed consent up to approximately 24 weeks post-delivery for mothers; up to approximately 96 weeks post birth for neonates ]
  • ● Number of Participants With Live Birth at or After Gestational Age (GA) Week 32 and no Intrauterine Transfusion (IUT) Throughout Their Entire Pregnancy [ Time Frame: Up to approximately GA Week 37 ]
  • ● Global Clinical Outcome (GCO) Rank Score (GCO Rank) [ Time Frame: Up to approximately GA Week 37; up to approximately 12 weeks post birth ]
  • ● Number of Participants With GCO Clinically Meaningful Classification (GCO Class) [ Time Frame: Up to approximately GA Week 37; up to approximately 12 weeks post birth ]
  • ● Number of Participants With live Birth [ Time Frame: Up to approximately GA Week 37 ]
  • ● Number of Participants at GA Week 24 Without an IUT [ Time Frame: GA Week 24 ]
  • ● Gestational age at First IUT [ Time Frame: Up to approximately GA Week 37 ]
  • ● Number of IUTs Required [ Time Frame: Up to approximately GA Week 37 ]
  • ● Gestational age at Delivery [ Time Frame: Up to approximately GA Week 37 ]
  • ● Number of Participants With Fetal Hydrops [ Time Frame: Up to approximately 24 weeks post birth ]
  • ● Number of Neonates Requiring Phototherapy [ Time Frame: Up to approximately 24 weeks post birth ]
  • ● Number of Neonates Requiring Exchange transfusions [ Time Frame: Up to approximately 24 weeks post birth ]
  • ● Number of Days of Postnatal Phototherapy Required by Neonate [ Time Frame: Up to approximately 24 weeks post birth ]
  • ● Number of Neonates Requiring Simple Transfusions in the First 12 weeks of Life [ Time Frame: Up to 12 weeks post birth ]
  • ● Number of Simple Transfusions Required by Neonate in the First 12 weeks of Life [ Time Frame: Up to 12 weeks post birth ]
  • ● Percentage of Maternal Fc Receptor (FcRn) Receptor Occupancy (RO) [ Time Frame: GA Week 14 to approximately GA Week 36 ]
  • ● Maternal Levels of Total Immunoglobulin G (IgG) [ Time Frame: GA Week 14 to approximately GA Week 36 ]
  • ● Maternal Levels of Alloantibodies [ Time Frame: GA Week 14 to approximately GA Week 36 ]
  • ● Mean Concentration of M281 in Maternal Participants [ Time Frame: GA Week 14 to approximately GA Week 36 ]

Links:

https://clinicaltrials.gov/ct2/show/NCT03842189

Enrollment:   Open

Study Type:   Interventional

Country:   Netherlands

Criteria:

"All (near)-term neonates (gestational age ≥ 35 weeks) admitted to the Leiden University Medical Center (LUMC) with HDFN, treated with IUT."

Outcome Measures:

  • ● Number of top-up transfusions required per infant in the first 3 months of life.
  • ● The percentage of infants requiring a top-up transfusion.
  • ● Number of days of admission for top-up transfusions
  • ● Occurrence of hypertension
  • ● Occurrence of high ferritin levels
  • ● Other Outcome Measures: Long-term neurodevelopmental outcome [ Time Frame: 2 years of age ]

Links:

https://clinicaltrials.gov/ct2/show/NCT03104426

Enrollment:   Open

Study Type:   Expanded Access

Country:   China

Criteria:

"Blood samples of pregnant couples, gender/nation/region is unlimited."

Outcome Measures:

  • ● None listed.

Links:

https://clinicaltrials.gov/ct2/show/NCT02969174

Enrollment:   Open

Study Type:   Interventional

Country:   Saudi Arabia

Criteria:

"Up to 14 days old. Healthy term and late-preterm neonates more than or equal to 35 weeks gestation with hemolytic disease of the newborn will be included. Enrolled infants should have evidence of hemolysis as defined by any of the following criteria: (1) positive DAT and blood group iso-immunization (ABO / RH incompatibility);and /or (2) HGB decline by 2g/dl within 24hours."

Outcome Measures:

  • ● Rebound hyperbilirubinemia: defined as the return of TSB to or beyond the AAP phototherapy threshold within 72 hours of phototherapy discontinuation of a neonate's first round of phototherapy treatment.
  • ● Duration of Phototherapy
  • ● Duration of hospital stay
  • ● Adverse effects related to phototherapy (Erythematous rash, loose stool, hyperthermia, and dehydration)
  • ● Rebound hyperbilirubinemia between 3-7 days after phototherapy stoppage
  • ● Rebound TSB level that exceeded the appropriate AAP phototherapy threshold by ≥35 µmol/L after phototherapy stoppage
  • ● Rebound TSB level that exceeded the appropriate AAP exchange transfusion threshold after phototherapy storage
  • ● Total Cost of NICU Care

Links:

https://clinicaltrials.gov/ct2/show/NCT04218318