A Clinical Research Study for Expectant Women at High Risk for Developing HDFN
If you are currently pregnant and have had a prior pregnancy with Hemolytic Disease of the Fetus and Newborn (HDFN), you may consider participating in the UNITY Study. This clinical research study will evaluate the safety and efficacy of an investigational drug in reducing the risk and severity of anemia in the fetus.
Hemolytic disease of the fetus and newborn (HDFN) is an immune system disorder that occurs when the blood types of a mother and fetus are incompatible.
Blood Types and Blood Group Proteins
In addition to the four major blood types (A, B, AB, and O), blood types are also determined by the presence or absence of something called a blood group protein, called an antigen.
When a woman becomes pregnant, the baby inherits genes from both parents, including blood type and blood group antigens. If the mother’s blood type has a negative antigen and the baby inherits a positive antigen blood type from the father, the mother’s immune system may begin making antibodies to attack the baby’s “foreign” red blood cells.
Typically, the immune system response is not strong enough to affect the first pregnancy. However, future pregnancies involving incompatible blood group antigens will often trigger a much stronger response. This immune response can lead to a number of serious health complications for the fetus, including severe anemia, jaundice, congestive heart failure, edema, and death.
Prevention and Treatment
While many cases of HDFN are largely preventable, those who require treatment for severe HDFN can be faced with intensive and invasive procedures (such as intrauterine transfusions), which may be associated with significant complications. What’s needed are new non-invasive, safe, and effective treatment options.
We are conducting the UNITY Study to investigate the safety and efficacy of an investigational drug for this medical need.
The Unity Study
The UNITY Study is a clinical research study for expectant women whose pregnancies are at high risk for developing HDFN. The Study is designed to help evaluate whether the investigational drug is safe and effective in reducing the risk and severity of anemia in the fetus.
Length of Participation
Approximately 12.5 months for the mother, with a 96 week follow-up for the infant
(Up to 6 weeks)
Study Treatment Period
(Approximately 20 weeks)
Post-natal Follow-up Period
(Approximately 24 weeks)
Infant Follow-up Period
(Approximately 96 weeks)
Study Treatment Delivery
Beginning at Week 14 of the pregnancy, study treatment will be delivered to the mother on a weekly basis via two-hour IV infusions
About the Investigational Drug
In HDFN, the mother’s immune system creates antibodies that attack the red blood cells of the fetus. Left untreated, the fetus can develop severe anemia and complications associated with the anemia such as jaundice, congestive heart failure, edema, or even death.
The investigational drug is intended to:
There is no placebo in the UNITY Study, which means all study participants will receive the investigational drug. It will be given via an infusion on a weekly basis until shortly before the baby is born. If necessary, study participants will switch to standard of care treatment (intrauterine transfusions) if the study doctor believes it is in the best interest of the pregnancy.
Potential Risks and Benefits
The investigational drug is not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory agency. It is not known if the investigational drug works or is safe. Your health may get better, worse, or not change at all. Please speak with your study doctor for more information about the potential risks and discomforts you may experience from participating in this study.
About Clinical Studies
Clinical studies allow us to investigate the potential of investigational drugs. All investigational drugs must be tested in clinical studies (also known as clinical research studies) before they are approved and available for use. This is done by testing on study participants, but only after the investigational drug in question has gone through extensive testing in the laboratory. There are guidelines, laws and protections for those participating in clinical trials. Participation in a study is completely voluntary, and participants can choose to stop participating at any time and for any reason.
Clinical research studies help scientists and doctors explore whether a medical strategy, investigational drug, or device is safe and effective. Study participants are critically important to clinical research. Without people willing to volunteer their time for medical research, it would be almost impossible to evaluate potential new treatments for medical conditions.
To learn more about clinical research studies, click here.
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