clinical trial · NCT02633943
Long-term Follow-up of Subjects With Transfusion-Dependent β-Thalassemia (TDT) Treated With Ex Vivo Gene Therapy
Transfusion-dependent Beta-ThalassemiaSafety and efficacy assessments
brief summary
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.
started
Jan 1, 2014
primary completion
Nov 1, 2035
completion
Nov 1, 2035
last updated
Apr 9, 2025
official title
Long-term Follow-up of Subjects With Transfusion-Dependent β-Thalassemia (TDT) Treated With Ex Vivo Gene Therapy Using Autologous Hematopoietic Stem Cells Transduced With a Lentiviral Vector
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol