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

Recruitingn/aAges 18 Years - anyAllChiesi Italia
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Male and female adults (โ‰ฅ 18 years). 2. Patients with a clinical diagnosis of Fabry disease confirmed by ฮฑ-Gal A assay and detection of mutation in ฮฑ-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.
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What it tests

  • pegunigalsidase alfa
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Where

7 sites
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
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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