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

NCT ID: NCT04628871

Last Updated: 2024-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-03

Study Completion Date

2030-01-01

Brief Summary

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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

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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

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Hemophilia B Mucopolysaccharidosis I Mucopolysaccharidosis II

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects who received SB-318

Subjects who received SB-318 in clinical study SB-318-1502

SB-318

Intervention Type BIOLOGICAL

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.

SB-913

Intervention Type BIOLOGICAL

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

SB-FIX

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sangamo Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor, MD

Role: STUDY_DIRECTOR

Sangamo Therapeutics

Locations

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UCSF Benioff Children's Hospital Oakland

Oakland, California, United States

Site Status

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Site Status

New York University Grossman School of Medicine

New York, New York, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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ST-IVPRP-LT01

Identifier Type: -

Identifier Source: org_study_id

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