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NCT06941025 · ClinicalTrials.gov registry record
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
A clinical trial of Pregnancy and Pregnancy Complications, sponsored by Chiesi Farmaceutici S.p.A..
- Recruiting
- Registry status
- 10
- Enrollment target
- 5
- Study locations
NCT06941025: Recruiting study of Pregnancy and Pregnancy Complications, sponsored by Chiesi Farmaceutici S.p.A..
NCT06941025 is a study of Pregnancy and Pregnancy Complications that is actively recruiting participants, run by Chiesi Farmaceutici S.p.A.. The registered enrollment target is 10 participants, below the 873-participant average among 191 other Pregnancy trials with a reported enrollment target (99% lower). The trial reports 5 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06941025, a study of Pregnancy and Pregnancy Complications, is actively recruiting participants, sponsored by Chiesi Farmaceutici S.p.A..
- RECRUITING
- Registry status
- 10 participants
- Enrollment target
- 5
- Study locations
Study 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.
Conditions Studied
Interventions
- OTHER Not applicable- observational study
Study Locations (5)
Other
- No physical study sites - Decentralized, web-based registry - Berlin
- No physical study sites - Decentralized, web-based registry - Rome
- No physical study sites - Decentralized, web-based registry - Madrid
- No physical study sites - Decentralized, web-based registry - London
District of Columbia
- No physical study sites - Decentralized, web-based registry - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2025-05-23 |
| Est. Completion | 2034-12 |
What NCT06941025 shows while recruiting
NCT06941025 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 873-participant average among 191 other Pregnancy trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Pregnancy appearing as the primary indexed condition, and to 1 intervention - of which Not applicable- observational study is the first listed.
NCT06941025 lists 5 locations in 2 states (Other, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT06941025 about?
NCT06941025 is a clinical study titled "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". 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 out...
What is the current status of trial NCT06941025?
This trial is currently recruiting. The enrollment target is 10 participants. The study started on 2025-05-23. Estimated completion is 2034-12.
What conditions does trial NCT06941025 study?
This clinical trial studies the following conditions: Pregnancy, Pregnancy Complications, Fabry Disease.
What interventions are being tested in trial NCT06941025?
The interventions under investigation include: Not applicable- observational study (OTHER).
Who is sponsoring clinical trial NCT06941025?
This trial is sponsored by Chiesi Farmaceutici S.p.A., which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06941025 being conducted?
This trial has 5 study locations across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06941025's enrollment target sits among peer trials
10 190th of 191 higher than 2 of 191 other Pregnancy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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