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NCT04628871 Clinical Trial

Long Term Follow-up (LTFU) of Subjects Who Received SB-318, SB-913, or SB-FIX

Hemophilia B Clinical Trial

— LTFU  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04628871
Other study ID # ST-IVPRP-LT01
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 3, 2020
Est. completion date January 1, 2030

Study information
Verified date May 2024
Source Sangamo Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 13
Est. completion date January 1, 2030
Est. primary completion date January 1, 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• 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.
• 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.
• 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.

Locations
Country Name City State
United States University of North Carolina Chapel Hill North Carolina
United States Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio
United States New York University Grossman School of Medicine New York New York
United States UCSF Benioff Children's Hospital Oakland Oakland California

Sponsors (1)
Lead Sponsor Collaborator
Sangamo Therapeutics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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