Status:
ACTIVE_NOT_RECRUITING
Long Term Follow-Up for Safety of AVR-RD-02
Lead Sponsor:
John Bernat
Conditions:
Gaucher Disease
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this observational study is to assess the safety and tolerability of AVR-RD-02 treatment in subjects who previously received AVR-RD-02 treatment (single dose administration).
Detailed Description
Subjects who received AVR-RD-02 in the preceding treatment study (NCT04145037) and who meet all eligibility criteria may participate. Subjects will be asked to return for study visits annually for 14 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Subjects must meet all of the following inclusion criteria for participation in this study:
- Subject must be willing and able to provide written informed consent for the JAB-GD-001 study in accordance with applicable regulations and guidelines and to comply with all study visits and procedures.
- Subject must have been enrolled in the preceding AVROBIO AVRO-RD-02-201 treatment study and have received AVR-RD-02 treatment
- Exclusion Criteria
- Subject has any medical, psychological, or other condition that, in the opinion of the Investigator:
- Might interfere with the subject's participation in the study (including consenting to procedures); and/or
- Poses any additional risk to the subject; and/or
- Might confound the results of any study-required assessments.
Exclusion
Key Trial Info
Start Date :
February 21 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2037
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT06488261
Start Date
February 21 2024
End Date
October 1 2037
Last Update
July 22 2025
Active Locations (1)
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1
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242