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

Plain-language summary

This study collects long-term safety data by following up participants who previously received one of the gene therapies SB-318, SB-913 or SB-FIX in earlier clinical trials. It enrolls people who received these treatments under the relevant study protocols and agreed to take part in the follow-up. The study is a non-phase study; it is not currently recruiting but is ongoing (active, not recruiting).

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Active, not recruiting

Sponsor

Sangamo Therapeutics

Intervention

SB-318, SB-913, SB-FIX

Start date

11/3/2020

Estimated completion

1/1/2030

Countries

United States

Related genes

Locations

• Oakland, United States
• Chicago, United States
• New York, United States
• Chapel Hill, United States
• Cincinnati, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine 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.