Fabry Disease Clinical Trials

• Male or female aged \> 18 years of age at the time of consent.

• Genetically confirmed diagnosis of Fabry disease.

• Either taking or planning to take pegunigalsidase alfa as treatment for Fabry disease.

• No contraindications for cardiac magnetic resonance imaging (cMRI)

• Informed consent form (ICF) signed and dated indicating the individual has been informed of and agreed to all pertinent aspects of the study and is willing to comply with all study requirements, including completion of electronic patient reported outcomes (ePROs).

• Cardiac Cohort:

• Evidence of Fabry disease (FD)-related heart disease including one or more of the following:

• Left ventricular hypertrophy (LVH) measured by left ventricular mass index (LVMI) (g/m2) elevation above age/sex specific reference ranges.

• Posterior septum wall thickness (e.g., \>=13mm) not explained by other factors (e.g., hypertension)

• Low native T1 mapping on cMRI.

• Typical Fabry-like scar on cMRI

• Participants can receive cardiac magnetic resonance imaging (cMRI) with gadolinium enhancement as part of their SoC.

• Estimated glomerular filtration rate (eGFR) \>45 mL/min/1.73 m2, assessed within the prior 6 months.

• Naïve Cohort:

• Most recent eGFR\>45 mL/min/1.73 m2, assessed within prior 6 months.

• Male participants should have abnormal elevation in plasma lysoGb3 as assessed within 6 months prior to enrolment.

• Long-Term Cohort:

• Participants previously enrolled in the open label study CLI-06657AA1-04 (Previously PB-102-F60) (using pegunigalsidase alfa at a dose of 1mg/kg every 2 weeks) who have initiated or plan to initiate commercial pegunigalsidase alfa (Elfabrio®).