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Observes safety of Elfabrio in pregnant women with Fabry disease and their infants

Observes pregnancy and infant outcomes in women with Fabry disease taking Elfabrio.

Key facts

Who runs it
Chiesi Farmaceutici S.p.A.
Where
Rome, ItalySee the siteAlso in 4 other countries, 4 sites
Trial code
Registry title
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
Status
Recruiting
People taking part
10 people, planned
Started
23 May 2025
Expected to end
Dec 2034
Type of study
Observational
Treatments tested
  • Not applicable- observational study
Record updated
19 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women with Fabry disease who received pegunigalsidase alfa shortly before pregnancy, during pregnancy, or while breastfeeding, and their infants.

Sex
Women (female patients)
Earlier treatment
Must have received at least 1 dose of pegunigalsidase alfa within 30 days before the start of pregnancy reference point (20/7 gestational weeks), during pregnancy, or during breastfeeding.

The registry criteria, word for word

Show all 3 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • None

Where in Italy

Also in 4 other countries, 4 sites

  • No physical study sites - Decentralized, web-based registryRome, ItalyContact: Chiesi Clinical TrialTaking people

About the trial

What the trial wants to find out

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 conception and/or during pregnancy and lactation.

Read full original descriptionShow less

The main objectives are to:

* Assess pregnancy outcomes, including maternal and infant health. * Evaluate the occurrence of congenital malformations and other neonatal outcomes.

This is a global, decentralized, single-arm, prospective and retrospective registry planned to enroll participants over a 10-year period. Eligible patients may be enrolled by their physician or may self-enroll, where permitted by local regulations. Data will be collected through a secure web-based platform, allowing patients and physicians to enter information via electronic case report forms (eCRFs).

Pregnancy and clinical outcomes will be documented throughout pregnancy and up to 12 months post-birth. Data from self-enrolled patients will be confirmed by their primary care or attending physician. This registry is observational and does not impact clinical care or treatment decisions.

The group in the trial

  • Women with Fabry disease who were exposed to pegunigalsidase alfa during pregnancy and/or lactation

    Treatment: Not applicable- observational study

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official 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 Alfa-iwxj/Pegunigalsidase Alfa) During Pregnancy and/or Lactation
Plain-language title
Observes safety of Elfabrio in pregnant women with Fabry disease and their infantsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
19 March 2026