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
| NCT ID | NCT06941025 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chiesi Farmaceutici S.p.A. |
| Condition | Fabry Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-05-23 |
| Primary Completion | 2034-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10 participants in total. It began in 2025-05-23 with a primary completion date of 2034-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * None
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06941025 clinical trial?
This trial is open to female participants only, studying Fabry Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06941025 currently recruiting?
Yes, NCT06941025 is actively recruiting participants. Contact the research team at clinicaltrials_info@chiesi.com for enrollment information.
Where is the NCT06941025 trial being conducted?
This trial is being conducted at Washington D.C., United States, Berlin, Germany, Rome, Italy, Madrid, Spain and 1 additional location.
Who is sponsoring the NCT06941025 clinical trial?
NCT06941025 is sponsored by Chiesi Farmaceutici S.p.A.. The trial plans to enroll 10 participants.