Pregnant women who are considering taking part in the study may consider the following:
Previously, six XLHED-affected boys received the investigational medicine before birth and the results indicated the potential to prevent or at least significantly reduce the severity of some XLHED symptoms. These were reported in scientific journals in 2018 and 2023.
We now want to confirm these findings in the Edelife study, with two aims:
If a pregnant woman is eligible, a doctor will infuse the investigational medicine into the water (amniotic fluid) around the baby at three time points between pregnancy weeks 26 and 32. During this stage of pregnancy, babies regularly swallow this fluid, and will therefore swallow the investigational medicine at the same time.
So far, the investigational medicine has not been found to have any major significant side effects, but it is a product in development and may have unknown side effects. Safety of the participant is always our first concern in a research study, and you and your child’s safety will be closely monitored throughout your participation in the Edelife study. If you would like more information on the potential risks and benefits associated with the investigational medicine, please ask a study doctor.
Participating in Edelife will require study-specific visits to a clinical center. Pregnant women must be at least 18 years of age and enrolled before week 23 of their pregnancy.
If you are interested in taking part in the study or you have questions, please contact a Study Doctor.