Clinical Trial

German Observational Multicenter Study of Patients With Fabry Disease Under Enzyme Replacement Therapy With Pegunigalsidase-alfa

Study acronym: GoPEG
Active, Not Recruiting
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Summary
Pegunigalsidase-alfa may represent an advance in ERT for FD, based on its unique pharmacokinetics and apparent low immunogenicity. The objective of the study is to document long term data on treatment with pegunigalsidase-alfa under "real world" conditions. 60 patients with FD (therapy-naïve or pretreated with agalsidase-alfa or agalsidase-beta) will be recruited in 8 German Fabry centers. The treatment duration/patient will be 2 years. All patients will be followed-up by the above listed Fabry expert centers.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-10-17; most recent amendment 2026-04-29.
Status change: Recruiting → Active, Not Recruiting 2026-04-29
Trial Details
NCT Number NCT06095713
Lead Sponsor Universität Münster
Collaborators: Chiesi GmbH
Conditions Fabry Disease
Enrollment 60 participants
Start Date 2023-10-01
Primary Completion 2027-09-30 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-30