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Maternal and Postnatal Outcomes Study (MOS) for Fabry Disease

This study is an observational registry looking at the safety of Elfabrio® (pegunigalsidase alfa) in women with Fabry disease during pregnancy and breastfeeding, and its effects on their babies. Researchers want to understand pregnancy outcomes like live births, preterm births, and pregnancy losses. They will also check for any birth defects or other health issues in the infants. You can join if you are a woman with Fabry disease who has received Elfabrio® shortly before or during pregnancy, or while breastfeeding, along with your baby. The study aims to enroll about 10 participants over 10 years.

Study design
This is an observational study, meaning researchers will collect information without giving any specific treatment. It is a single-arm study, meaning all participants receive the same observation, and aims to enroll 10 participants.
What's involved
You or your doctor will provide information through a secure online platform. Data will be collected from when you enroll until your baby is 12 months old.
Compensation
Not stated in the trial record.
Follow-up
Your health and your baby's health will be monitored from enrollment until your baby reaches 12 months of age.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06941025

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

Recruiting
Not specifiedAll AgesObservational
Chiesi Farmaceutici S.p.A.
~10 participants
Updated 2026-03-19 on ClinicalTrials.gov
What's tested:Not applicable- observational study

At a glance

Recruiting sites
4 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pregnancy outcome: Number of live births
Measured over at the delivery, after an average of 40 weeks of pregnancy
+2 more outcomes measured

Conditions

Fabry Disease
Pregnancy
Pregnancy Complications

Explore related trials

Fabry Disease

Where it's being run

5 sites across 5 states
District of Columbia1
Germany1
Italy1
Spain1
United Kingdom1

Who to contact

Chiesi Clinical Trial
[email protected]
+3905212791
Email the study team

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Do you actually qualify for this trial?

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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.
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

What this trial measures

  • Pregnancy outcome: Number of live birthsat the delivery, after an average of 40 weeks of pregnancy
  • Pregnancy outcome: Number of preterm birthat delivery, prior to 37 weeks of gestation
  • Pregnancy outcome: Number of pregnancy losses (number of spontaneous abortions , number of pregnancy terminations, number of foetal deaths or stillbirths)spontaneous abortions: up to 20 weeks of pregnancy; pregnancy terminations: through the pregnancy; number of foetal deaths or stillbirths: greater than 20 weeks of pregnancy and through the pregnancy, average of 40 weeks