Fabry Patient's Experience Of PegunigaLsidasE Alfa Monthly Infusion

Study Identifier:
CLI-06657AA1-05
ClinicalTrials.gov Identifier:
NCT05186324
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete

Trial Documents

Plain Language Summary
Available Languages: Danish, Dutch, English, Italian
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Study Details

Medical Condition
  • Fabry Disease
Study Drug
    Date
    Jan 2022 - Aug 2022
    Phase 1
    Phase 2
    Phase 3
    Phase 4
    N/A
    Patient Requirements
    Sex: Female & Male
    Age: N/A
    Requirements Information
    Inclusion and Exclusion Criteria
    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.
    Healthy Volunteers
    No

    Protocol 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 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).

    Study Locations

    Location
    Status
    Location
    #02
    Birmingham, Alabama, United States, 35233
    Status
    N/A
    Location
    #03
    Atlanta, Georgia, United States, 30322
    Status
    N/A
    Location
    #04
    Iowa City, Iowa, United States, 52242
    Status
    N/A
    Location
    #11
    Grand Rapids, Michigan, United States, 49525
    Status
    N/A
    Location
    #06
    Dallas, Texas, United States, 75246
    Status
    N/A
    Location
    #05
    Salt Lake City, Utah, United States, 84132
    Status
    N/A
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