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NCT05039866 Clinical Trial

Long-Term Follow-up of Subjects Who Were Treated With ST-920

Fabry Disease Clinical Trial

Official title:
Long-Term Follow-up of Fabry Disease Subjects Who Were Treated With ST-920, an AAV2/6 Human Alpha Galactosidase A Gene Therapy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05039866
Other study ID # ST-920-LT01
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date August 16, 2021
Est. completion date June 2029

Study information
Verified date April 2024
Source Sangamo Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Long-term follow-up of subjects who received ST-920 in a previous trial (ST-920-201) and completed at least 52 weeks post-infusion follow-up in their primary protocol. Enrolled subjects will be followed for a total of up to 5 years following ST-920 infusion.

Description:

Non-interventional, multi-center, long-term follow-up (LTFU) study of subjects dosed with ST-920 in the clinical study ST-920-201. All subjects dosed in the study who completed at least 52 weeks post-infusion follow-up in their primary protocol will be offered to participate. Subjects who enroll will be monitored for a total of up to 5 years following ST-920 infusion.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 48
Est. completion date June 2029
Est. primary completion date June 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subjects who received ST-920 therapy in a separate parent trial - Subjects who have consented to participate in this LTFU study. Exclusion Criteria: -This study has no exclusion criteria

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• ST-920
No study drug is administered in this study. Subjects who received ST-920 in a separate parent trial will be evaluated in this trial for long-term safety.

Locations
Country Name City State
Australia The Royal Melbourne Hospital Parkville Victoria
United Kingdom Addenbrooke's Hospital Cambridge
United States Emory University School of Medicine Atlanta Georgia
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio
United States Lysosomal & Rare Disorders Research & Treatment Center (LDRTC) Fairfax Virginia
United States University of Iowa Hospital and Clinics Iowa City Iowa
United States University of California, Irvine Irvine California
United States University of Minnesota Medical Center Minneapolis Minnesota
United States Mt. Sinai Hospital New York New York

Sponsors (1)
Lead Sponsor Collaborator
Sangamo Therapeutics

Countries where clinical trial is conducted

United States,  Australia,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate long-term safety of ST-920 To evaluate long-term safety of ST-920 by assessment of incidence and severity of adverse events (AEs) 4 years
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