Fabry Patient's Experience Of PegunigaLsidasE Alfa Monthly Infusion
Completed
Conditions studied: Fabry Disease
In brief
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 and clinician-reported outcomes have been included, this may not allow for a sufficiently accurate assessment of the quality of life in patients with Fabry Disease treated with pegunigalsidase alfa. This study will collect the patient experience on the pegunigalsidase alfa treatment administered intravenously every 4 weeks in the BRIGHT-F51 clinical study (NCT03614234).
Key facts
- Study ID
- NCT05186324
- Run by
- Chiesi Farmaceutici S.p.A.
- People needed
- 23
- Starts
- 2022-01-26
- Expected to finish
- 2022-08-31
- Last updated by the study team
- 2023-03-21
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- #02 — Birmingham, Alabama, United States
- #03 — Atlanta, Georgia, United States
- #04 — Iowa City, Iowa, United States
- #11 — Grand Rapids, Michigan, United States
- #06 — Dallas, Texas, United States
- #05 — Salt Lake City, Utah, United States
- #01 — Fairfax, Virginia, United States
- #22 — Antwerp, Belgium
- #50 — Copenhagen, Denmark
- #56 — Naples, Italy
- #28 — Cambridge, United Kingdom
- #07 — London, United Kingdom
Full record on ClinicalTrials.gov
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