New registry aims to fill gap on fabry drug safety in pregnancy
NCT ID NCT06941025
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This 10-year observational registry will follow up to 10 women with Fabry disease who received pegunigalsidase alfa (Elfabrio) around the time of pregnancy or while breastfeeding, along with their infants. Researchers will track pregnancy outcomes, birth defects, and infant health up to 12 months after birth. The study does not change any treatment decisions—it simply collects real-world safety information.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
pegunigalsidase alfa (Elfabrio)
What this could lead to
If successful, this study could provide crucial safety data on using pegunigalsidase alfa during pregnancy and breastfeeding for women with Fabry disease.
What could go wrong
This is a small observational registry (10 participants) with no control group, so results may not apply broadly. It only collects data, not testing a new treatment.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Study contacts
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
Locations
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No physical study sites - Decentralized, web-based registry
RECRUITINGWashington D.C., District of Columbia, 20001, United States
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No physical study sites - Decentralized, web-based registry
RECRUITINGBerlin, Germany
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No physical study sites - Decentralized, web-based registry
RECRUITINGRome, Italy
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No physical study sites - Decentralized, web-based registry
RECRUITINGMadrid, Spain
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No physical study sites - Decentralized, web-based registry
NOT_YET_RECRUITINGLondon, United Kingdom