B-MORE

• Research type

  Research Study

• Full title

  B-MORE study: A Real World Prospective Observational Study of the Treatment and Outcomes of Patients with Haemophilia B Initiating Treatment with Alprolix

• IRAS ID

  265203

• Contact name

  Michael Laffan

• Contact email

  m.laffan@imperial.ac.uk

• Sponsor organisation

  Swedish Orphan Biovitrum

• Clinicaltrials.gov Identifier

  NCT03901755

• Clinicaltrials.gov Identifier

  NCT03901755, NCTnumber

• Duration of Study in the UK

  3 years, 6 months, 0 days

• Research summary

  This is a 24-month prospective, non-interventional, international, multicentre study to describe the real-world effectiveness and usage of Alprolix in patients with haemophilia B in selected European and Middle Eastern countries.
  the patient will also be asked to complete questionnaires assessing their satisfaction with Alprolix treatment, physical activity and quality of life. There will be about 75 people enrolled in this study. This study will be carried out in 8 European countries and the Middle East at approximately 25 different research sites or hospitals in total.

• REC name

  London - Camden & Kings Cross Research Ethics Committee

• REC reference

  19/LO/1030

• Date of REC Opinion

  18 Oct 2019

• REC opinion

  Further Information Favourable Opinion