Status:
COMPLETED
Fabry Patient's Experience Of PegunigaLsidasE Alfa Monthly Infusion
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Collaborating Sponsors:
Protalix
Iqvia Pty Ltd
Conditions:
Fabry Disease
Eligibility:
All Genders
Brief Summary
Pegunigalsidase alfa (PRX-102) is a long-term enzyme replacement therapy design for the treatment of patients with Fabry disease. Although in the clinical development program patient-reported outcomes...
Detailed Description
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 intravenous...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 26 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT05186324
Start Date
January 26 2022
End Date
August 31 2022
Last Update
March 21 2023
Active Locations (12)
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1
#02
Birmingham, Alabama, United States, 35233
2
#03
Atlanta, Georgia, United States, 30322
3
#04
Iowa City, Iowa, United States, 52242
4
#11
Grand Rapids, Michigan, United States, 49525