A Global Prospective Observational Study of Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY
This is a global prospective observational study of women with Fabry disease and their infants during pregnancy and/or breastfeeding. The study will evaluate outcomes of pregnancy and/or breastfeeding in women and infants exposed to migalastat.
Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:
⁃ Female patients meeting the following criteria will be eligible for study enrollment:
• Patients with Fabry disease who are pregnant and/or breastfeeding, whether or not they are exposed to migalastat
• Able and willing to provide informed consent or assent, if applicable.
• Able and willing to provide HCP contact information.
Locations
United States
Pennsylvania
Amicus Therapeutics, Inc. Pregnancy Registry
RECRUITING
Philadelphia
Contact Information
Primary
Pregnancy Registry Call Center
galafoldpregnancy@ubc.com
888-239-0758
Time Frame
Start Date: 2025-03-18
Estimated Completion Date: 2030-02
Participants
Target number of participants: 20
Treatments
Cohort 1
Cohort 1 will be pregnant and/or breastfeeding patients who have Fabry Disease, and have been exposed to at least 1 dose of migalastat during pregnancy and/or breastfeeding.
Cohort 2
Cohort 2 will be pregnant and/or breastfeeding patients who have Fabry Disease, who were not exposed to migalastat during pregnancy and/or breastfeeding.
Related Therapeutic Areas
Sponsors
Leads: Amicus Therapeutics