Observational Prospective Cohort Study on Long-term Effective and Safe Use of Pegunigalsidase Alfa in Adult Fabry Patients Under Real-world Setting
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Italy
AUSL Toscana Sud-Est - Ospedale San Donato
NOT_YET_RECRUITING
Arezzo
Azienda Ospedaliera Universitaria Consorziale Policlinico Di Bari
RECRUITING
Bari
Irccs Azienda Ospedaliero-Universitaria Di Bologna - Policlinico Di Sant'Orsola
RECRUITING
Bologna
A.O. Sant'Anna e San Sebastiano
NOT_YET_RECRUITING
Caserta
U.O.C. Nefrologia ASST Monza - Ospedale San Gerardo
NOT_YET_RECRUITING
Monza
AOU Federico II, Dipartimento di Nefrologia
NOT_YET_RECRUITING
Naples
A.O.U. Policlinico Giaccone
NOT_YET_RECRUITING
Palermo
Contact Information
Primary
Chiesi Clinical Trial info
clinicaltrials_info@chiesi.com
+3905212791
Time Frame
Start Date: 2026-06-15
Estimated Completion Date: 2029-02
Participants
Target number of participants: 75
Treatments
Fabry patients
Adult patients whit genetically confirmed diagnosis of Fabry disease being treated or planning to start treatment with Pegunigalsidase alfa according to clinical practice. Participants will be required to meet the inclusion and exclusion criteria and sign informed consent to be enrolled in the study.
Related Therapeutic Areas
Sponsors
Leads: Chiesi Italia