Clinical study to evaluate INTERCEPT RBC in Thalassemia patients v5.0

• Research type

  Research Study

• Full title

  A Randomized Controlled Study to Evaluate Efficacy and Safety of INTERCEPT Treated Red Blood Cells (RBC) in Subjects with Thalassemia Major Requiring Chronic RBC Transfusion

• IRAS ID

  186440

• Contact name

  John Porter

• Contact email

  j.porter@ucl.ac.uk

• Sponsor organisation

  Cerus Corporation

• Eudract number

  2012-002920-33

• Clinicaltrials.gov Identifier

  NCT01740531

• Duration of Study in the UK

  2 years, 1 months, 30 days

• Research summary

  The objective of this Phase 3 study is to evaluate the efficacy and safety of INTERCEPT treated Red Blood Cells (RBC) in subjects who require chronic transfusion support due to thalassemia major. This study is designed to support the licensure of a medical device, the INTERCEPT Blood System for Red Blood Cells.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  15/LO/1611

• Date of REC Opinion

  17 Nov 2015

• REC opinion

  Further Information Favourable Opinion