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

Sponsor
Chiesi Italia
Study ID
NCT07109375
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Aug 7, 2025
Start date
Jun 15, 2026
Status verified
Jul 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2029

Study Design

Enrollment
75 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Assessment of structural abnormalities of the left ventricle [ Time Frame: 24 months ]

Central Contacts

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