Long-Term Follow-up of Subjects Who Were Treated With ST-920

NCT ID: NCT05039866

Last Updated: 2025-05-25

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

ENROLLING_BY_INVITATION

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-16

Study Completion Date

2039-03-31

Brief Summary

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Long-term follow-up of subjects who received ST-920 in a previous trial (ST-920-201) 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 5 years following ST-920 infusion.

Detailed Description

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Non-interventional, multi-center, long-term follow-up (LTFU) study of subjects dosed with ST-920 in the clinical study ST-920-201. All subjects dosed in the study who 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 5 years following ST-920 infusion.

Conditions

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Fabry Disease Fabry Disease, Cardiac Variant

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects who received ST-920

Subjects who received ST-920 in a separate parent trial

ST-920

Intervention Type BIOLOGICAL

No study drug is administered in this study. Subjects who received ST-920 in a separate parent trial will be evaluated in this trial for long-term safety.

Interventions

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ST-920

No study drug is administered in this study. Subjects who received ST-920 in a separate parent trial will be evaluated in this trial for long-term safety.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subjects who received ST-920 therapy in a separate parent trial
* Subjects who have consented to participate in this LTFU 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

Role: STUDY_DIRECTOR

Sangamo Therapeutics, Inc.

Locations

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University of California, Irvine

Irvine, California, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

Emory University School of Medicine

Atlanta, Georgia, United States

Site Status

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

Site Status

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Site Status

Mt. Sinai Hospital

New York, New York, United States

Site Status

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Lysosomal & Rare Disorders Research & Treatment Center (LDRTC)

Fairfax, Virginia, United States

Site Status

The Royal Melbourne Hospital

Parkville, Victoria, Australia

Site Status

M.A.G.I.C. Clinic Ltd.

Calgary, Alberta, Canada

Site Status

University Hospital of Würzburg

Würzburg, , Germany

Site Status

Addenbrooke's Hospital

Cambridge, , United Kingdom

Site Status

Royal Free Hospital

London, , United Kingdom

Site Status

Countries

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United States Australia Canada Germany United Kingdom

Other Identifiers

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ST-920-LT01

Identifier Type: -

Identifier Source: org_study_id

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