NCT07109375Recruiting
Observational Study on Long-term Use of Pegunigalsidase Alfa in Fabry Patients in a Real-world Setting
Observational Prospective Cohort Study on Long-term Effective and Safe Use of Pegunigalsidase Alfa in Adult Fabry Patients Under "Real-world" Setting
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 75 (estimated)
- First submitted
- 10 Jul 2025
- Start date
- 15 Jun 2026
- Primary completion date
- Feb 2029
- Lead sponsor
- Chiesi Italia
- Diseases
- Fabry disease
- NCT number
- NCT07109375
What you commit to
- Study type: Observational
- Planned participants: 75
- From 15 Jun 2026 to the primary completion date, Feb 2029
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Female subjects who are pregnant or planning to become pregnant during the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AUSL Toscana Sud-Est - Ospedale San Donato Coordinator of this site? Confirm its status | Arezzo | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari Coordinator of this site? Confirm its status | Bari | Italy | Recruiting |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| A.O. Sant'Anna e San Sebastiano Coordinator of this site? Confirm its status | Caserta | Italy | Not yet recruiting |
| U.O.C. Nefrologia ASST Monza - Ospedale San Gerardo Coordinator of this site? Confirm its status | Monza | Italy | Not yet recruiting |
| AOU Federico II, Dipartimento di Nefrologia Coordinator of this site? Confirm its status | Naples | Italy | Not yet recruiting |
| A.O.U. Policlinico Giaccone Coordinator of this site? Confirm its status | Palermo | Italy | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.