Status:
NOT_YET_RECRUITING
Maternal and Postnatal Outcomes Study (MOS): A Global Observational Registry Assessing the Safety of Elfabrio® in Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Collaborating Sponsors:
ICON plc
Conditions:
Fabry Disease
Pregnancy
Eligibility:
FEMALE
Brief Summary
The goal of this observational registry is to evaluate the safety and outcomes of pregnancy and lactation in women with Fabry disease who are exposed to pegunigalsidase alfa within 30 days prior to co...
Detailed Description
This is a global, decentralized, single-arm, prospective and retrospective observational registry designed to evaluate pregnancy and infant outcomes in women with Fabry disease who have been exposed t...
Eligibility Criteria
Inclusion
- Female patients with Fabry disease who have been exposed to at least 1 dose of pegunigalsidase alfa at any time during pregnancy (defined as having received pegunigalsidase alfa within 30 days prior to the DOC and/or during pregnancy) and/or during lactation, and their infants.
- o DOC, defined as 20/7 gestational weeks, will be calculated from last menstrual period \[LMP\] or ultrasound
- Patient or parent/legally authorized representative must be able to understand and provide consent through an Institutional Review Board / Independent Ethics Committee (IRB/IEC) approved Informed Consent Form.
Exclusion
- None
Key Trial Info
Start Date :
June 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2034
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06941025
Start Date
June 1 2025
End Date
December 1 2034
Last Update
April 23 2025
Active Locations (5)
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1
No physical study sites - Decentralized, web-based registry
Washington D.C., District of Columbia, United States, 20001
2
No physical study sites - Decentralized, web-based registry
Berlin, Germany
3
No physical study sites - Decentralized, web-based registry
Rome, Italy
4
No physical study sites - Decentralized, web-based registry
Madrid, Spain