An open-label study of LentiGlobin BB305 in paediatric patients with beta thalassaemia major
Phase of Trial: Phase II
Latest Information Update: 07 Aug 2015
At a glance
- Drugs BB305 beta-globin gene therapy bluebird bio (Primary)
- Indications Beta-thalassaemia
- Focus Therapeutic Use
- 07 Aug 2015 According to bluebird bio media release, NIH RAC review of HGB-207 (see 700257159) and HGB-208 study protocols in adult and adolescent patients with beta-thalassemia major and pediatric patients with beta-thalassemia major, respectively have been completed.
- 21 May 2015 New trial record
- 19 May 2015 bluebird bio plans to pursue conditional and accelerated registration strategies in EU and US, respectively. Company filed clinical study protocol for HGB-208 study with the NIH Recombinant DNA Advisory Committee (RAC) and was notified that HGB-208 study protocol is scheduled for public review on June 9, 2015. The data from this and three other studies (HGB-205, HGB-207 and HGB-208) will support the Biologics License Application (BLA) submission for LentiGlobin BB305.