Fabry Patient's Experience Of PegunigaLsidasE Alfa Monthly Infusion

This is an additional qualitative concept elicitation interview-based study to further understand the patients' experience with Fabry disease and with the pegunigalsidase alfa administered intravenously every 4 weeks. Patients will be asked a set of open-ended questions with probes to describe their experiences with Fabry disease on treatment with pegunigalsidase alfa. Qualitative research methods will be used to obtain a deeper understanding of the patient experience by generating in-depth information about the experiences, perspectives, and feelings of patients and others, in their own words (FDA Patient-Focused Drug Development Guidance 2).

The study will be offered to the 29 patients participating in the BRIGHT-F51 clinical trial (NCT03614234).

Inclusion criteria

• The patient is participating in study PB-102-F51
• The patient is willing and able to participate in a 60-minute recorded interview
• The patient is able to read, understand, and speak sufficiently to participate in the interviews
• The patient signs informed consent to participate in the study

Exclusion criteria

• At investigators discretion, patient is considered to be unable to participate in a 60- minute telephone interview.
• Patient has any clinically relevant medical or psychiatric condition that, in the opinion of the investigator would interfere with the completion of the study activities. This includes but is not limited to language, speech, hearing or cognitive disorders that could impact a patient's ability to participate in an interview-based discussion.