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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects who received ST-920 | Subjects who received ST-920 in a separate parent trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ST-920 | Biological | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
-This study has no exclusion criteria
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All subjects who have received ST-920 in separate parent trial and who have consented to participate in this Long Term Follow-up study.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Sangamo Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine | Irvine | California | 92697 | United States | ||
| University of South Florida |
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plasma, serum
| Tampa |
| Florida |
| 33620 |
| United States |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | United States |
| University of Iowa Hospital and Clinics | Iowa City | Iowa | 52242 | United States |
| University of Minnesota Medical Center | Minneapolis | Minnesota | 55455 | United States |
| Mt. Sinai Hospital | New York | New York | 10029 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Lysosomal & Rare Disorders Research & Treatment Center (LDRTC) | Fairfax | Virginia | 22030 | United States |
| The Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| M.A.G.I.C. Clinic Ltd. | Calgary | Alberta | T2E 7Z4 | Canada |
| University Hospital of Würzburg | Würzburg | Germany |
| Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| Royal Free Hospital | London | United Kingdom |
| ID | Term |
|---|---|
| D000795 | Fabry Disease |
| C567062 | Fabry Disease, Cardiac Variant |
| ID | Term |
|---|---|
| D013106 | Sphingolipidoses |
| D020140 | Lysosomal Storage Diseases, Nervous System |
| D020739 | Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D059345 | Cerebral Small Vessel Diseases |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008661 | Metabolism, Inborn Errors |
| D008064 | Lipidoses |
| D008052 | Lipid Metabolism, Inborn Errors |
| D016464 | Lysosomal Storage Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D052439 | Lipid Metabolism Disorders |
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