๐๏ธ Verified NIH Record โข Updated 2025-07-02
A Global Prospective Observational Study of Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding (NCT04252066)
๐ข Recruiting Interventional Protocol ๐ Observational Clinical Research Sponsor: Amicus Therapeutics
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Amicus Therapeutics, Inc. Pregnancy Registry โ Philadelphia, Pennsylvania
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- Amicus Therapeutics, Inc. Pregnancy Registry โ Philadelphia, Pennsylvania
๐ Contact the Study Coordinator
Phone: (888) 239-0758
Email: galafoldpregnancy@ubc.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Fabry Disease
- A Study to Evaluate the Effect of Venglustat Tablets on Neuropathic and Abdominal Pain in Male and Female Participants โฅ16 Years of Age With Fabry Disease โ Birmingham, Alabama
- A Study to Evaluate the Long-term Safety and Tolerability of Lucerastat in Adult Subjects With Fabry Disease โ Birmingham, Alabama
- Long-Term Follow-up of Subjects Who Were Treated With ST-920 โ Irvine, California
- An Open-label, Phase 1/2 Trial of Gene Therapy 4D-310 in Adults With Fabry Disease โ La Jolla, California
- A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease โ Birmingham, Alabama
- A Study to Evaluate Migalastat in Fabry Subjects With Amenable GLA Variant and Renal Disease โ Atlanta, Georgia
Explore by condition: All Fabry Disease clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.