About the Azalea Trial
The purpose of the Azalea Trial is to evaluate the efficacy and safety of an investigational medication in pregnancies at risk for severe hemolytic disease of the fetus and newborn (HDFN).
For more information, download the participant fact sheet.- Participation in this clinical trial includes approximately 20–23 weekly intravenous (IV) infusions while visiting the trial clinic during your pregnancy. There are about 27 total visits to the clinic before the birth of your child.
- After your child’s birth, you will have 3 additional trial clinic visits over the course of 6 months, and your child will have 6 trial clinic visits over the course of 2 years.
- As a participant in the Azalea Trial, you will be randomly assigned to receive an infusion of either the active investigational medication or a placebo (placebo looks like the investigational medication but does not contain any active medication). You have a 2-in-3 chance of receiving the investigational medication.
All participants will receive trial-required medication and trial-required medical care at no cost. Participants will also be reimbursed for trial-required travel and expenses. You will not be paid for other medical care or medications that are not part of the trial.
The investigational medication has not been approved for use by the FDA.
For more information, download the placebo fact sheet.