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RecruitingNCT07109375

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

Sponsor

Chiesi Italia

Enrollment

75 participants

Start Date

Jun 15, 2026

Study Type

OBSERVATIONAL

Conditions

Fabry Disease

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called pegunigalsidase alfa for people with fabry disease. The study is currently recruiting participants at 7 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGpegunigalsidase alfa

Pegunigalsidase alfa is 2 mg/mL concentrate for solution and is administered via intravenous infusion every two weeks.

Locations(7)

AUSL Toscana Sud-Est - Ospedale San Donato

Arezzo, Italy

Azienda Ospedaliera Universitaria Consorziale Policlinico Di Bari

Bari, Italy

Irccs Azienda Ospedaliero-Universitaria Di Bologna - Policlinico Di Sant'Orsola

Bologna, Italy

A.O. Sant'Anna e San Sebastiano

Caserta, Italy

U.O.C. Nefrologia ASST Monza - Ospedale San Gerardo

Monza, Italy

AOU Federico II, Dipartimento di Nefrologia

Naples, Italy

A.O.U. Policlinico "Giaccone"

Palermo, Italy

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NCT07109375

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