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

To evaluate outcomes of pregnancy and/or breastfeeding in women and infants exposed to migalastat. Collect data as described in this protocol for a minimum of 10 years.

CT.gov Identifier
NCT04252066
EudraCT Identifier
N/A
CTIS:
N/A
Sponsor
Amicus Therapeutics
Collaborator
N/A
Study Contact Information
+1 609 662 2000
Recruiting
Contact Us

Study Details

Diseases
Fabry Disease
Study Drug
Migalastat hydrochloride
Genes
GLA
Study Dates
Apr 2020 - Aug 2029
Sex
Female
Age
N/A
Inclusion and Exclusion Criteria
Inclusion Criteria:
  • Patients with Fabry disease who are pregnant and/or breastfeeding, whether or not they are exposed to migalastat
  • Able and willing to provide informed consent or assent, if applicable.
  • Able and willing to provide HCP contact information.
Exclusion Criteria:
  • None

Protocol Summary

To evaluate outcomes of pregnancy and/or breastfeeding in women and infants exposed to migalastat.

Collect data as described in this protocol for a minimum of 10 years.

Study Locations

To view all trial locations, click here

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