Clinical trial

A Study Evaluating the Efficacy and Safety of the LentiGlobin® BB305 Drug…

NCT02906202 · Genetix Biotherapeutics Inc., Industry · Completed

Key facts

NCT number NCT02906202
Title A Study Evaluating the Efficacy and Safety of the LentiGlobin® BB305 Drug Product in Participants With Transfusion-Dependent β-Thalassemia, Who do Not Have a β0/β0 Genotype
Official title A Phase 3 Single Arm Study Evaluating the Efficacy and Safety of Gene Therapy in Subjects With Transfusion-dependent β-Thalassemia, Who do Not Have a β0/β0 Genotype, by Transplantation of Autologous CD34+ Stem Cells Transduced Ex Vivo With a Lentiviral βA-T87Q-Globin Vector in Subjects ≤50 Years of…
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 24
Start date Aug 8, 2016
Primary completion Mar 31, 2022
Completion Mar 31, 2022
First posted Sep 20, 2016
Last update posted Jun 18, 2023
Countries France, Germany, Italy, Thailand, United Kingdom, United States

At a glance

  • 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:

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