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

  352703

• Contact name

  Cristina Violi

• Contact email

  c.violi@chiesi.com

• Sponsor organisation

  Chiesi Farmaceutici S.p.A

• Duration of Study in the UK

  10 years, 0 months, 1 days

• Research summary

  This is a worldwide, decentralized, single arm, prospective and retrospective, observational registry in women with Fabry disease exposed to pegunigalsidase alfa during pregnancy (within 30 days prior to the date of conception and/or during pregnancy) and/or lactation, and their infants.The registry will allow eligible patients to self enrol. Patient enrolment and data collection will be coordinated through a centralised web based platform.

• REC name

  North West - Preston Research Ethics Committee

• REC reference

  25/NW/0250

• Date of REC Opinion

  15 Aug 2025

• REC opinion

  Unfavourable Opinion