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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Chiesi Farmaceutici S.p.A.
Study ID
NCT06941025
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Not applicable- observational study — OTHER
    Not applicable - observational study

Study Details

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. 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.

Key Dates

Start date
May 23, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2034
Completion
Dec 31, 2034

Study Design

Enrollment
10 participants (estimated)

Arms

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

Primary Outcome Measure

Pregnancy outcome: Number of live births [ Time Frame: at the delivery, after an average of 40 weeks of pregnancy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
No physical study sites - Decentralized, web-based registryWashington D.C.District of Columbia20001-

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No physical study sites - Decentralized, web-based registry· Washington D.C., DC

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