This is a worldwide voluntary observational pregnancy and lactation study that Amicus Therapeutics, Inc. is conducting. The aim of this registry is to collect valuable health information regarding the pregnancies of women who have Fabry disease and the infant up through 1 year of age. The health information learned from this registry will be shared with the U.S. Food and Drug Administration (FDA) and other regulatory agencies and may help other women who have Fabry disease to better understand the impact the disease and its treatments might have on pregnancies and child development.
This voluntary registry will enroll women with Fabry disease who become pregnant or who are breastfeeding within the first year of their child's birth. This voluntary registry will enroll treated and untreated women, with Fabry disease, who are/were pregnant or who are/were breastfeeding within the first year of their child's birth.
To enroll a patient or to request additional information:
If a patient is eligible for participation, she will be asked to review an informed consent document containing details about the registry and to sign a form that allows collection of personal health information from healthcare providers involved in the care of her pregnancy and that of her infant.
Your patient's participation in the observational pregnancy registry may last throughout her pregnancy and up to one year after her delivery date. Your patient will be contacted once per trimester, at the estimated date of delivery, and if she is breastfeeding, when her infant is 3, 6, 9, and 12 months of age to provide basic health information about her pregnancy, post pregnancy health and her infant's health. At each timepoint your patient will be asked to confirm her contact information.
A healthcare provider's (HCP) participation depends on if they are treating the patient or infant. The woman's obstetric HCP will be contacted around the 8th month of the patient's pregnancy and, again, within 4 weeks around the estimated delivery date. The pediatric HCP will be contacted when the baby is approximately 3, 6, 9, and 12 months old. In order to collect the health information, The Pregnancy Coordinating Center will send questionnaires to the appropriate HCP for completion. If your patient enrolls into the registry but does not wish to be contacted by the Pregnancy Coordinating Center all pregnancy and infant health information will be collected from the HCP.
All data provided by you and/or your patient will be entered into the registry database. The registry database will be kept on a secure computer system maintained by United BioSource, LLC (UBC) in accordance with their written security policy. Information about your patient's health collected while they are in the Fabry Pregnancy Registry will be kept in confidence and in accordance with privacy statutes and regulations.
The success of the Fabry Pregnancy Registry depends on the continued participation of healthcare providers like you. We greatly appreciate your help with identifying and enrolling patients in the registry, and in assisting with the collection of follow-up information during your patient's participation in the registry.