Status:
TERMINATED
A Long-Term Follow-up Study of Subjects With Gaucher Disease Who Previously Received AVR-RD-02
Lead Sponsor:
AVROBIO
Conditions:
Type 1 Gaucher Disease
Eligibility:
All Genders
18-99 years
Brief Summary
This is a multicenter, multinational long-term follow-up study to assess the long-term safety and durability of effect of AVR-RD-02 treatment in subjects who previously received AVR-RD-02 treatment (s...
Detailed Description
Subjects who received AVR-RD-02 in the preceding treatment study and who meet all eligibility criteria may participate in the AVRO-RD-02-LTF01 study. For individual participating subjects, the Baselin...
Eligibility Criteria
Inclusion
- Subject must have been enrolled and received AVR-RD-02 as single dose administration
- Subject must be willing and able to provide written informed consent for the AVRO-RD-02-LTF01 study in accordance with applicable regulations and guidelines and to comply with all study visits and procedures.
Exclusion
- Subject is currently enrolled in an AVROBIO-sponsored AVR-RD-02 treatment study.
Key Trial Info
Start Date :
July 6 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 21 2023
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04836377
Start Date
July 6 2021
End Date
August 21 2023
Last Update
August 29 2023
Active Locations (3)
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1
University of Iowa
Iowa City, Iowa, United States, 52242
2
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
3
M.A.G.I.C. Clinic Ltd
Calgary, Calgary Alberta, Canada, T2M 0L6