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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05039866
Recruitment Status : Enrolling by invitation
First Posted : September 10, 2021
Last Update Posted : April 25, 2023
Sponsor:
Information provided by (Responsible Party):
Sangamo Therapeutics

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Fabry Disease Fabry Disease, Cardiac Variant Biological: ST-920

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 48 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : August 16, 2021
Estimated Primary Completion Date : June 2028
Estimated Study Completion Date : June 2029

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Subjects who received ST-920
Subjects who received ST-920 in a separate parent trial
 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.


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate long-term safety of ST-920 [ Time Frame: 4 years ]
    To evaluate long-term safety of ST-920 by assessment of incidence and severity of adverse events (AEs)


Biospecimen Retention:   Samples With DNA
plasma, serum

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All subjects who have received ST-920 in separate parent trial and who have consented to participate in this Long Term Follow-up study.
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05039866


Locations
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United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
United States, Iowa
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242
United States, New York
Mt. Sinai Hospital
New York, New York, United States, 10029
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Virginia
Lysosomal & Rare Disorders Research & Treatment Center (LDRTC)
Fairfax, Virginia, United States, 22030
United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Sponsors and Collaborators
Sangamo Therapeutics
Investigators
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Study Director: Medical Monitor Sangamo Therapeutics, Inc.
More Information
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Responsible Party: Sangamo Therapeutics
ClinicalTrials.gov Identifier: NCT05039866    
Other Study ID Numbers: ST-920-LT01
First Posted: September 10, 2021    Key Record Dates
Last Update Posted: April 25, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sangamo Therapeutics:
Fabry Disease
Gene Therapy
ST-920
Rare
 Genetic
DNA
Sangamo
Long Term
Additional relevant MeSH terms:
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Fabry Disease
Sphingolipidoses
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
 Vascular Diseases
Cardiovascular Diseases
Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Metabolism, Inborn Errors
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases
Lipid Metabolism Disorders