Condition: Fabry Disease · Pregnancy · Pregnancy Complications · Sponsor: Chiesi Farmaceutici S.p.A.
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.
This description comes directly from the study's public registry record.
Chiesi Clinical Trial · +3905212791 · clinicaltrials_info@chiesi.com
Always discuss trial participation with your own doctor first.
| No physical study sites - Decentralized, web-based registry | Washington D.C., District of Columbia, United States | Recruiting |
| No physical study sites - Decentralized, web-based registry | Berlin, Germany | Recruiting |
| No physical study sites - Decentralized, web-based registry | Rome, Italy | Recruiting |
| No physical study sites - Decentralized, web-based registry | Madrid, Spain | Recruiting |
| No physical study sites - Decentralized, web-based registry | London, United Kingdom | Not Yet Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT06941025