Chiesi Maternal and Postnatal Outcomes Study (MOS)
Research type
Research Study
Full title
Maternal and Postnatal Outcomes Study (MOS) A worldwide decentralized observational registry to evaluate the safety in women with Fabry disease and their infants exposed to Elfabrio® (pegunigalsidase alfaiwxj/pegunigalsidase alfa) during pregnancy and/or lactation
IRAS ID
366345
Contact name
Cyril P Clarke
Contact email
Sponsor organisation
Chiesi Farmaceutici S.p.A
Research summary
This is a worldwide, decentralized, observational registry in women with Fabry disease exposed to Elfabrio®
(pegunigalsidase alfa) during pregnancy and/or during lactation, and their infants.
This registry is conducted by Chiesi as a Post-Marketing Requirement (PMR) to the US Food and Drug Administration
(FDA).
The participation in the registry is voluntary.
As a decentralized study, there is no physical site. An ICON' s expert will act as Principal Investigator for administrative
tasks. This ICON Principal Investigator will not be in direct contact with the Participant nor her Health Care Providers
and will not interact at all in the medical care and treatment of the Participant. Medical care and treatment resides
within the Participants' Health Care Providers.
Registry data will be collected into a virtual secured platform with restricted access. The Participant or her Health Care
Provider will be providing the data. ICON will facilitate the data collection, if needed.REC name
London - South East Research Ethics Committee
REC reference
25/PR/1735
Date of REC Opinion
2 Feb 2026
REC opinion
Further Information Favourable Opinion