SCient Clinical Study CLI 00110

• Research type

  Research Study

• Full title

  A randomized, controlled, double-blinded crossover study to evaluate the efficacy and safety of the Red Blood Cell (RBC) concentrates processed with the INTERCEPT Blood System (INTERCEPT) in patients with Sickle Cell Disease in an exchange transfusion program (SCient)

• IRAS ID

  236358

• Contact name

  John Brooke Porter

• Contact email

  j.porter@ucl.ac.uk

• Sponsor organisation

  Cerus Corporation

• Eudract number

  2018-000530-35

• Duration of Study in the UK

  1 years, 2 months, 31 days

• Research summary

  This study is designed to support the US licensure of the medical device, INTERCEPT Blood System for Red Blood Cells (RBC).The objectives of this study are to evaluate the safety and efficacy of pathogen inactivated RBCs prepared with the INTERCEPT Blood System for RBCs for the transfusion support of subjects with chronic anemia due to sickle cell disease treated in an automated Red Cell Exchange (RCE) transfusion program compared to automated RCE transfusions with conventional RBCs.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  18/NW/0420

• Date of REC Opinion

  3 Feb 2020

• REC opinion

  Further Information Favourable Opinion