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Clinical trial

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

ID
Name
ST-IVPRP-LT01
Description
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 arms
Trial start
2020-11-03
Estimated PCD
2030-01-01
Trial end
2030-01-01
Status
Active (not recruiting)
Treatment
SB-318
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.
Arms:
Subjects who received SB-318
SB-913
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.
Arms:
Subjects who received SB-913
SB-FIX
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.
Arms:
Subjects who received SB-FIX
Size
13
Primary endpoint
Long-term safety
10 years
Eligibility criteria
Inclusion Criteria: 1. 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 2. Subjects who have provided consent to participate in the LTFU study. Exclusion Criteria: 1. Unable to comply with study visit schedule or study visit procedures. 2. Any other reason that, in the opinion of the Investigator or Medical Monitor, would render the subject unsuitable for participation in the study.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'plasma, serum'}, 'enrollmentInfo': {'count': 13, 'type': 'ESTIMATED'}}
Updated at
2024-05-03

1 organization

3 products

3 indications

Organization
Sangamo Therapeutics
Product
SB-318
Indication
Hemophilia B
Indication
Mucopolysaccharidosis Type I
Indication
MPS II
Product
SB-913
Product
SB-FIX