Long Term Follow-up (LTFU) of Subjects Who Received SB-318, SB-913, or SB-FIX
LTFU
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
1 other identifier
observational
13
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2020
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 3, 2020
CompletedFirst Submitted
Initial submission to the registry
November 9, 2020
CompletedFirst Posted
Study publicly available on registry
November 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2030
May 3, 2024
May 1, 2024
9.2 years
November 9, 2020
May 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Long-term safety
Long-term safety of SB-318, SB-913, and SB-FIX by assessment of any newly-diagnosed or worsening of existing medical conditions.
10 years
Study Arms (3)
Subjects who received SB-318
Subjects who received SB-318 in clinical study SB-318-1502
Subjects who received SB-913
Subjects who received SB-913 in clinical study SB-913-1602.
Subjects who received SB-FIX
Subjects who received SB-FIX in clinical study SB-FIX
Interventions
No study drug is administered in this study. Subject who received SB-318 in a previous trial will be evaluated in this trial for long-term safety.
No study drug is administered in this study. Subject who received SB-913 in a previous trial will be evaluated in this trial for long-term safety.
No study drug is administered in this study. Subject who received SB-FIX in a previous trial will be evaluated in this trial for long-term safety.
Eligibility Criteria
All subjects who have received SB-318 in Study Protocol SB-318-1502, SB-913 in Study Protocol SB-913-1602 or SB-FIX in Study Protocol SB-FIX-1501 and who have consented to participate in this Long Term Follow-up study.
You may qualify if:
- Subjects who received SB-318 under Study Protocol SB-318-1502, SB-913 under Study Protocol SB-913-1602, or SB-FIX under Study Protocol SB-FIX-1501
- Subjects who have provided consent to participate in the LTFU study.
You may not qualify if:
- Unable to comply with study visit schedule or study visit procedures.
- Any other reason that, in the opinion of the Investigator or Medical Monitor, would render the subject unsuitable for participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
New York University Grossman School of Medicine
New York, New York, 10016, United States
University of North Carolina
Chapel Hill, North Carolina, 27514, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Biospecimen
plasma, serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor, MD
Sangamo Therapeutics
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2020
First Posted
November 16, 2020
Study Start
November 3, 2020
Primary Completion (Estimated)
January 1, 2030
Study Completion (Estimated)
January 1, 2030
Last Updated
May 3, 2024
Record last verified: 2024-05