Observational Study on Long-term Use of Pegunigalsidase Alfa in Fabry Patients in a Real-world Setting

Study Identifier:
CHIT-2401
ClinicalTrials.gov Identifier:
NCT07109375
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
+3905212791 or [email protected]
Recruiting

Study Details

Medical Condition
  • Fabry Disease
Study Drug
  • Drug: pegunigalsidase alfa
Date
Jun 2026 - Feb 2029
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • 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 Criteria
  • 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.
Healthy Volunteers
No

Protocol 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.

Study Locations

Location
Status
Location
AUSL Toscana Sud-Est - Ospedale San Donato
Arezzo, Italy
Status
Not yet recruiting
Location
Azienda Ospedaliera Universitaria Consorziale Policlinico Di Bari
Bari, Italy
Status
Recruiting
Location
Irccs Azienda Ospedaliero-Universitaria Di Bologna - Policlinico Di Sant'Orsola
Bologna, Italy
Status
Recruiting
Location
A.O. Sant'Anna e San Sebastiano
Caserta, Italy
Status
Not yet recruiting
Location
U.O.C. Nefrologia ASST Monza - Ospedale San Gerardo
Monza, Italy
Status
Not yet recruiting
Location
AOU Federico II, Dipartimento di Nefrologia
Naples, Italy
Status
Not yet recruiting
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