Observational Study on Long-term Use of Pegunigalsidase Alfa in Fabry Patients in a Real-world Setting
Recruiting now
Conditions studied: Fabry Disease
In brief
PEGASO is an observational study designed to collect prospective data on the effectiveness and safety of pegunigalsidase alfa in adult patients with Fabry disease, being treated or planning to start treatment, under real-world setting.
Key facts
- Study ID
- NCT07109375
- Run by
- Chiesi Italia
- People needed
- 75
- Starts
- 2026-06-15
- Expected to finish
- 2029-02-01
- Last updated by the study team
- 2026-07-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and female adults (≥ 18 years).
- Patients with a clinical diagnosis of Fabry disease confirmed by α-Gal A assay and detection of mutation in α-Gal A gene.
- Patients either taking or planning to take pegunigalsidase alfa as treatment for Fabry disease. The treatment decision must be made independently from participation in this study.
- Written informed consent to participate in the study and for the processing of personal data.
You may not qualify if…
- History of hypersensitivity reaction to pegunigalsidase alfa.
- Presence of any medical, emotional, behavioural, or psychological condition that, in the judgment of the physician, could interfere with the ability to participate in the study.
- Female subjects who are pregnant or planning to become pregnant during the study.
Where it is running
- Azienda Ospedaliera Universitaria Consorziale Policlinico Di Bari — Bari, Italy (enrolling)
- Irccs Azienda Ospedaliero-Universitaria Di Bologna - Policlinico Di Sant'Orsola — Bologna, Italy (enrolling)
- U.O.C. Nefrologia ASST Monza - Ospedale San Gerardo — Monza, Italy
- AOU Federico II, Dipartimento di Nefrologia — Naples, Italy
- A.O.U. Policlinico "Giaccone" — Palermo, Italy
- A.O. Sant'Anna e San Sebastiano — Caserta, Italy
- AUSL Toscana Sud-Est - Ospedale San Donato — Arezzo, Italy
Full record on ClinicalTrials.gov
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