NCT07109375 Observational Study on Long-term Use of Pegunigalsidase Alfa in Fabry Patients in a Real-world Setting
| NCT ID | NCT07109375 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chiesi Italia |
| Condition | Fabry Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 75 participants |
| Start Date | 2026-06-15 |
| Primary Completion | 2029-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 75 participants in total. It began in 2026-06-15 with a primary completion date of 2029-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Male and female adults (≥ 18 years). 2. Patients with a clinical diagnosis of Fabry disease confirmed by α-Gal A assay and detection of mutation in α-Gal A gene. 3. 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. 4. Written informed consent to participate in the study and for the processing of personal data. Exclusion Criteria: 1. History of hypersensitivity reaction to pegunigalsidase alfa. 2. 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. 3. Female subjects who are pregnant or planning to become pregnant during the study.
Contact & Investigator
Antonio Pisani, MD
PRINCIPAL INVESTIGATOR
AOU Federico II, Dipartimento di Nefrologia, Napoli, Italy
Frequently Asked Questions
Who can join the NCT07109375 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fabry Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07109375 currently recruiting?
Yes, NCT07109375 is actively recruiting participants. Contact the research team at clinicaltrials_info@chiesi.com for enrollment information.
Where is the NCT07109375 trial being conducted?
This trial is being conducted at Arezzo, Italy, Bari, Italy, Bologna, Italy, Caserta, Italy and 3 additional locations.
Who is sponsoring the NCT07109375 clinical trial?
NCT07109375 is sponsored by Chiesi Italia. The principal investigator is Antonio Pisani, MD at AOU Federico II, Dipartimento di Nefrologia, Napoli, Italy. The trial plans to enroll 75 participants.