NCT05039866

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

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 48 (estimated)
• Sponsor: Sangamo Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Fabry Disease
• Fabry Disease, Cardiac Variant

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-08-16
• Primary completion: 2029-03-01
• Completion: 2039-03-01
• First posted: 2021-09-10
• Last updated: 2025-05-25

Locations

13 sites across 5 countries: United States, Australia, Canada, Germany, United Kingdom

Regulatory

• FDA-regulated drug study