NCT04252066 A Global Prospective Observational Study of Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding
| NCT ID | NCT04252066 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Amicus Therapeutics |
| Condition | Fabry Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-03-18 |
| Primary Completion | 2029-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2025-03-18 with a primary completion date of 2029-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04252066 clinical trial?
This trial is open to female participants only, studying Fabry Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04252066 currently recruiting?
Yes, NCT04252066 is actively recruiting participants. Contact the research team at galafoldpregnancy@ubc.com for enrollment information.
Where is the NCT04252066 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT04252066 clinical trial?
NCT04252066 is sponsored by Amicus Therapeutics. The trial plans to enroll 20 participants.