New registry aims to fill gap on fabry drug safety in pregnancy

NCT ID NCT06941025

Recruiting now Knowledge-focused Sponsor: Chiesi Farmaceutici S.p.A. Source: ClinicalTrials.gov ↗

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.

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Conditions

The condition(s) this trial relates to.

Fabry disease pregnancy disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

FABRY DISEASE PREGNANCY PREGNANCY COMPLICATIONS

Contacts and locations

Locations

No physical study sites - Decentralized, web-based registry
RECRUITING

Washington D.C., District of Columbia, 20001, United States
No physical study sites - Decentralized, web-based registry
RECRUITING

Berlin, Germany
No physical study sites - Decentralized, web-based registry
RECRUITING

Rome, Italy
No physical study sites - Decentralized, web-based registry
RECRUITING

Madrid, Spain
No physical study sites - Decentralized, web-based registry
NOT_YET_RECRUITING

London, United Kingdom

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