Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04628871
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2020-11-09
Brief Title:
Long Term Follow-up LTFU of Subjects Who Received SB-318 SB-913 or SB-FIX
Sponsor:
Sangamo Therapeutics
Organization:
Sangamo Therapeutics
Study Overview
Official Title:
Long-Term Follow-up of Subjects Who Were Treated With SB-318 SB-913 or SB-FIX for Targeted Genome Editing Into the Albumin Gene in the Liver
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LTFU
Brief Summary:
Long-term follow-up of subjects who received SB-318 SB-913 or SB-FIX in a previous trial 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 10 years following exposure to SB-318 SB-913 or SB-FIX
Detailed Description:
Non-interventional multi-center long-term follow-up LTFU study of subjects dosed with SB-318 in the clinical study SB-318-1502 SB-913 in the clinical study SB-913-1602 and SB-FIX in clinical study SB-FIX-1501 All subjects dosed in the studies and 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 10 years following exposure to the respective investigational products
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None