A Global Prospective Observational Study of Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding
NCT04252066 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20
Last updated 2025-07-08
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.
Conditions
Interventions
- DRUG
-
migalastat
This is an observational study. Patients as described in Cohort 1 should have been exposed to at least 1 dose of migalastat during pregnancy and/or breastfeeding.
Sponsors & Collaborators
-
Amicus Therapeutics
lead INDUSTRY
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-18
- Primary Completion
- 2029-08-31
- Completion
- 2030-02-28
- FDA Drug
- Yes
Countries
- United States
Study Locations
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