Clinical trial
A Study Evaluating the Efficacy and Safety of the LentiGlobin® BB305 Drug…
NCT03207009 · Genetix Biotherapeutics Inc., Industry · Completed
Key facts
| NCT number | NCT03207009 |
|---|---|
| Title | A Study Evaluating the Efficacy and Safety of the LentiGlobin® BB305 Drug Product in Participants With Transfusion-Dependent β-Thalassemia |
| Official title | A Phase 3 Single Arm Study Evaluating the Efficacy and Safety of Gene Therapy in Subjects With Transfusion-dependent β-Thalassemia by Transplantation of Autologous CD34+ Stem Cells Transduced Ex Vivo With a Lentiviral βA-T87Q-Globin Vector in Subjects ≤50 Years of Age |
| Lead sponsor | Genetix Biotherapeutics Inc., Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Beta-Thalassemia |
| Intervention type | Genetic |
| Interventions | LentiGlobin BB305 Drug Product |
| Enrollment | 19 |
| Start date | Jun 8, 2017 |
| Primary completion | Nov 15, 2022 |
| Completion | Nov 15, 2022 |
| First posted | Jul 2, 2017 |
| Last update posted | Mar 7, 2024 |
| Countries | France, Germany, Greece, Italy, United Kingdom, United States |
At a glance
- 1–9 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: