1321.3 – reversal of dabigatran by idarucizumab (BI655075).

• Research type

  Research Study

• Full title

  A Phase III, case series clinical study of the reversal of the anticoagulant effects of dabigatran by intravenous administration of 5.0g idarucizumab (BI 655075) in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.

• IRAS ID

  148007

• Contact name

  Steven Austin

• Contact email

  steve.austin@stgeorges.nhs.uk

• Sponsor organisation

  Boehringer Ingelheim

• Eudract number

  2013-004813-41

• ISRCTN Number

  n/a

• Research summary

  This is a Phase 3, case series clinical study of the reversal of the anticoagulant effects of dabigatran by intravenous administration of 5.0g idarucizumab in patients treated with dabigataran etexilate who have uncontrolled bleeding or require emergency surgery or procedures. The study is a multi-center trial involving approximately 600 sites and it is expected that approximately 200-300 patients will be entered into this trial over a period of 3 years.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  14/EE/0152

• Date of REC Opinion

  27 Jun 2014

• REC opinion

  Further Information Favourable Opinion