Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05039866




Registration number
NCT05039866
Ethics application status
Date submitted
20/08/2021
Date registered
10/09/2021
Date last updated
10/04/2024

Titles & IDs
Public title
Long-Term Follow-up of Subjects Who Were Treated With ST-920
Scientific title
Long-Term Follow-up of Fabry Disease Subjects Who Were Treated With ST-920, an AAV2/6 Human Alpha Galactosidase A Gene Therapy
Secondary ID [1] 0 0
ST-920-LT01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fabry Disease 0 0
Fabry Disease, Cardiac Variant 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - ST-920

Subjects who received ST-920 - Subjects who received ST-920 in a separate parent trial


Other interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate long-term safety of ST-920
Timepoint [1] 0 0
4 years

Eligibility
Key inclusion criteria
- Subjects who received ST-920 therapy in a separate parent trial

- Subjects who have consented to participate in this LTFU study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-This study has no exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2029
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Virginia
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Cambridge

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sangamo Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05039866
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Sangamo Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05039866