Pregnancy and postpartum outcomes after pegunigalsidase alfa exposure in women with Fabry disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This global, decentralized registry will collect both retrospective and prospective data on pregnancies and infant health when mothers with Fabry disease were exposed to pegunigalsidase alfa within 30 days prior to conception or during pregnancy or lactation. Enrollment is planned over a 10-year period and participants may be entered by their clinician or may self-enroll where local regulations permit, with data entered through a secure web-based platform and electronic case report forms. Pregnancy outcomes, delivery details, reported congenital malformations (adjudicated by an independent Scientific Advisory Committee), and infant health up to 12 months of age will be documented. The registry is observational, does not dictate treatment, and collects real-world safety and outcome data without exclusion criteria beyond exposure and ability to consent.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

Study contacts

• Study coordinator: Chiesi Clinical Trial
• Email: clinicaltrials_info@chiesi.com
• Phone: +3905212791

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.