Observational study of women with Fabry disease during pregnancy and breastfeeding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This global prospective observational study focuses on women with Fabry disease and their infants during pregnancy and breastfeeding. It aims to evaluate the outcomes of these experiences in women and infants who have been exposed to the treatment migalastat. The study will enroll two cohorts: one of women who have been treated with migalastat and another of those who have not. Data will be collected over a minimum of 10 years, with ongoing follow-up through the Pregnancy Coordinating Center.

Why it matters

Who can join: the full rules

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

Where it's running

• Amicus Therapeutics, Inc. Pregnancy Registry
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Pregnancy Registry Call Center
• Email: galafoldpregnancy@ubc.com
• Phone: 888-239-0758

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Quality of life for people 65+ with Fabry disease, treated or untreated

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• Agalsidase alfa for heart inflammation in Fabry disease measured by PET‑CMR

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.