Observes long-term pegunigalsidase alfa use in adults with Fabry disease
Follows adults with Fabry disease who take pegunigalsidase alfa in everyday care.
Plain-language title generated from the registry record
Registry title: Observational Study on Long-term Use of Pegunigalsidase Alfa in Fabry Patients in a Real-world Setting
Key facts
- Where
- Arezzo, Bari, Bologna, Caserta, Monza, Naples, and Palermo, ItalySee the 7 sites
Where in Italy
- AUSL Toscana Sud-Est - Ospedale San DonatoArezzo, ItalyNot yet recruiting
- Azienda Ospedaliera Universitaria Consorziale Policlinico di BariBari, ItalyTaking people
- IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'OrsolaBologna, ItalyTaking people
- A.O. Sant'Anna e San SebastianoCaserta, ItalyNot yet recruiting
- U.O.C. Nefrologia ASST Monza - Ospedale San GerardoMonza, ItalyNot yet recruiting
- AOU Federico II, Dipartimento di NefrologiaNaples, ItalyNot yet recruiting
- A.O.U. Policlinico GiacconePalermo, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chiesi Italia
- Trial code
- NCT07109375
- Record updated
- 8 July 2026
- Original description
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.Read full original descriptionShow less
Observational Prospective Cohort Study on Long-term Effective and Safe Use of Pegunigalsidase Alfa in Adult Fabry Patients Under "Real-world" Setting
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.
Inclusion: 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.
Exclusion: 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.