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Active (not recruiting) NCT02633943

Long-term Follow-up of Subjects With Transfusion-Dependent β-Thalassemia (TDT) Treated With Ex Vivo Gene Therapy

Conditions: Transfusion-dependent Beta-Thalassemia

Sponsor: Genetix Biotherapeutics Inc.

trial.available_in: БГ
Overview
This is a multi-center, long-term safety and efficacy follow-up study for subjects with transfusion-dependent β-thalassemia (TDT) who have been treated with ex vivo gene therapy drug product in bluebird bio-sponsored parent clinical studies. After completing the parent clinical studies (approximately 2 years), eligible subjects will be followed for an additional 13 years for a total of 15 years post-drug product infusion. No investigational drug product will be administered in this study.
Who can participate
Inclusion Criteria: * Provision of written informed consent for this study by subjects, or as applicable, subject's parent(s)/legal guardian(s) * Treated with drug product for therapy of transfusion-dependent β-thalassemia in a bluebird bio-sponsored clinical study Exclusion Criteria: * There are no exclusion criteria for this study
Locations 8
Australia (1)
Sydney
France (1)
Marseille
Germany (1)
Hanover
Greece (1)
Thessaloniki
Italy (1)
Rome
Thailand (1)
Bangkok
United Kingdom (1)
London
United States (1)
Oakland , California
Technical details
Status
Active (not recruiting)
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
0 Years
Maximum age
50 Years
Healthy volunteers
No
Start date
01.01.2014
Completion date
01.11.2035
Registry ID
NCT02633943
Source
anzctr
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