Long-Term Follow-up of Subjects Who Were Treated With ST-920
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ST-920.
- Who it may be relevant to
- Registry conditions: Fabry Disease, Fabry Disease, Cardiac Variant. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada, Germany, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- 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.
Primary outcome measures
- To evaluate long-term safety of ST-920 [Time frame: 4 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 8 centers
- University of California, Irvine — Irvine
- University of South Florida — Tampa
- Emory University School of Medicine — Atlanta
- University of Iowa Hospital and Clinics — Iowa City
- University of Minnesota Medical Center — Minneapolis
- Mt. Sinai Hospital — New York
- Cincinnati Children's Hospital Medical Center — Cincinnati
- Lysosomal & Rare Disorders Research & Treatment Center (LDRTC) — Fairfax
United Kingdom · 2 centers
- Addenbrooke's Hospital — Cambridge
- Royal Free Hospital — London
Australia · 1 center
- The Royal Melbourne Hospital — Parkville
Canada · 1 center
- M.A.G.I.C. Clinic Ltd. — Calgary
Germany · 1 center
- University Hospital of Würzburg — Würzburg
Identifiers
NCT: NCT05039866 · ST-920-LT01