NCT04628871

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

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
• Phase: —
• Study type: Observational
• Enrollment: 13 (estimated)
• Sponsor: Sangamo Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemophilia B
• Mucopolysaccharidosis I
• Mucopolysaccharidosis II

Interventions

Type	Name	Description
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.
BIOLOGICAL	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.
BIOLOGICAL	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.

Timeline

• Start date: 2020-11-03
• Primary completion: 2030-01-01
• Completion: 2030-01-01
• First posted: 2020-11-16
• Last updated: 2024-05-03

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study