Trial Profile

An open-label study of LentiGlobin BB305 in paediatric patients with beta thalassaemia major

Status: Planning

Phase of Trial: Phase II

Latest Information Update: 10 Aug 2015

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At a glance

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.

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