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Clinical Trials in the USA / NCT04252066
Recruiting Observational

A Global Prospective Observational Study of Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding

NCT04252066 · tracked via the Priya Life Science USA tracker
Sponsor
Amicus Therapeutics
Phase
Observational
Started
2025-03-18
Last updated
2026-10-28

Condition(s) studied

Fabry Disease

Investigational drug(s) / intervention(s)

migalastat →

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.

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.

Eligibility

Sex
FEMALE
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: Female patients meeting the following criteria will be eligible for study enrollment: 1. Patients with Fabry disease who are pregnant and/or breastfeeding, whether or not they are exposed to migalastat 2. Able and willing to provide informed consent or assent, if applicable. 3. Able and willing to provide HCP contact information. Exclusion Criteria: None

Primary outcome measure(s)

  • Number of major birth defects — Through the pregnancy, an average of 40 weeks and up to 12 months of infant age

Trial sites (1)

FacilityCityRegionStatus
Amicus Therapeutics, Inc. Pregnancy Registry Philadelphia Pennsylvania Recruiting

On this site

📄 Galafold (migalastat) drug profile →

More Amicus Therapeutics trials in the USA

A Study to Evaluate the Safety, Efficacy, PK, PD and Immunogenicity of Cipaglucosidase Alfa/Miglustat in IOPD Subjects Aged 0 to <18 Recruiting
A Study of Migalastat in Pediatric Subjects (2 to <12 Yrs) With Fabry Disease and Amenable GLA Variants Recruiting
A Study of Patients With Fabry Disease (US Specific) Recruiting
A Global Prospective Observational Registry of Patients With Pompe Disease Recruiting
ZIP Study-OL Study of Safety, PK, Efficacy, PD, Immunogenicity of ATB200/AT2221 in Pediatrics Aged 0 to < 18 y.o. w/LOPD Active, not recruiting

Other trials for the same condition

A Study of Migalastat in Pediatric Subjects (2 to <12 Yrs) With Fabry Disease and Amenable GLA Variants Recruiting
A Study to Evaluate the Effect of Venglustat Tablets on Neuropathic and Abdominal Pain in Male and Female Participants ≥16 Years of Age With Fabry Disease Active, not recruiting
Fabry Disease Registry & Pregnancy Sub-registry Recruiting
A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease Active, not recruiting
A Multi-Country Observational Study of Safety and Effectiveness of Elfabrio® in Fabry Patients Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04252066 on ClinicalTrials.gov ↗ ← All trials in the USA