Long Term Follow-up (LTFU) of Subjects Who Received SB-318, SB-913, or SB-FIX (LTFU)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04628871|
Recruitment Status : Active, not recruiting
First Posted : November 16, 2020
Last Update Posted : September 26, 2023
|Condition or disease||Intervention/treatment|
|Hemophilia B Mucopolysaccharidosis I Mucopolysaccharidosis II||Biological: SB-318 Biological: SB-913 Biological: SB-FIX|
|Study Type :||Observational|
|Estimated Enrollment :||13 participants|
|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|
|Actual Study Start Date :||November 3, 2020|
|Estimated Primary Completion Date :||January 1, 2030|
|Estimated Study Completion Date :||January 1, 2030|
Subjects who received SB-318
Subjects who received SB-318 in clinical study SB-318-1502
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.
Subjects who received SB-913
Subjects who received SB-913 in clinical study SB-913-1602.
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.
Subjects who received SB-FIX
Subjects who received SB-FIX in clinical study 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.
- Long-term safety [ Time Frame: 10 years ]Long-term safety of SB-318, SB-913, and SB-FIX by assessment of any newly-diagnosed or worsening of existing medical conditions.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04628871
|United States, California|
|UCSF Benioff Children's Hospital Oakland|
|Oakland, California, United States, 94609|
|United States, Illinois|
|Ann & Robert H. Lurie Children's Hospital of Chicago|
|Chicago, Illinois, United States, 60611|
|United States, New York|
|New York University Grossman School of Medicine|
|New York, New York, United States, 10016|
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27514|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Study Director:||Medical Monitor, MD||Sangamo Therapeutics|