REG-501: A Registry of Patients with β-Thalassemia Treated with Betibeglogene Autotemcel

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/42440
• EU PAS number:
  EUPAS36487
• Study ID:
  42440
• Official title and acronym:
  REG-501: A Registry of Patients with β-Thalassemia Treated with Betibeglogene Autotemcel
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  REG-501-DE is a country-specific observational registry study conducted to collect longitudinal data on the clinical outcomes of patients with β-thalassemia treated in Germany with Betibeglogene Autotemcel (also known by the tradename Zynteglo or as LentiGlobin BB305 Drug Product).
• Study status:
  Ongoing

Research institutions and networks

Institutions

Bluebird bio

Study timelines

Date when funding contract was signed

Planned: 24/05/2019

Actual: 24/05/2019

Study start date

Planned: 30/09/2020

Actual: 11/02/2021

Date of interim report, if expected

Planned: 31/12/2024

Date of final study report

Planned: 31/12/2042

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

bluebird bio, Inc

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)