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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04252066 on ClinicalTrials.gov