The registry is an observational, prospective, restrospective pregnancy and breastfeeding study that Amicus Therapeutics Inc. is conducting. This means that no drug is part of the program, and your current treatment or care will not change in any way as a result of your participation. The aim of this registry is to collect valuable health information regarding the pregnancies and/or breastfeeding of women who have Fabry disease and the infant up through 1 year of age. Amicus Therapeutics, Inc. is working with United BioSource LLC (UBC), a company with a Pregnancy Coordinating Center, which will collect all registry health information.
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.
Information submitted to the registry will be maintained as confidential in accordance with applicable national privacy regulations and other state and local laws related to medical information.
Pregnant and/or breastfeeding patients who have Fabry disease and have been exposed to at least 1 dose of Galafold® (migalstat) during pregnancy and/or breastfeeding.
Pregnant and/or breastfeeding patients who have Fabry disease.
BY PHONE-Call the Pregnancy Coordinating Center at
ONLINE-"Click" on the link to Report a Pregnancy
Provide your contact information and someone from the Pregnancy Coordinating Center will contact you to confirm necessary information to complete the registration. You may also ask your healthcare provider to enroll you. If you are eligible and would like to participate and live in the U.S. you will be asked to provide verbal informed consent to acknowledge your understanding of the registry and to provide your permission for your personal or infant healthcare information to be collected. After consent is received, a registry representative will contact your healthcare provider to confirm your personal health information. The Medical Information Release (MIR) will need to be completed and returned before the Pregnancy Coordinating Center can contact your healthcare provider.
Your participation in the registry may last throughout your pregnancy and up to one year after your delivery date. You will be asked to provide information about your medical history, past pregnancies (if applicable) and current health. You will be contacted once per trimester, at the estimated date of delivery, and when your baby is 3, 6, 9, and 12 months of age to provide information about your pregnancy, post pregnancy health, breastfeeding (if applicable) or your infant's health. At each time point, you will be asked to confirm your contact information.Informed Consent Form (ICF) Medical Information Release (MIR) form