Einstein Junior Phase II: Paediatric oral rivaroxaban (BAY59-7939)

• Research type

  Research Study

• Full title

  30 Day, open label, active controlled, randomized study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties of oral rivaroxaban in young children with various manifestations of venous thrombosis.

• IRAS ID

  155280

• Contact name

  Tina Biss

• Contact email

  Tina.biss@nuth.nhs.uk

• Sponsor organisation

  Bayer Public Limited Company

• Eudract number

  2014-000566-22

• Research summary

  The purpose of this study is to find out whether Rivaroxaban is safe to use in children and how long it stays in the body. Safety will be assessed by looking at the incidence and types of bleeding events. There will also be a check for worsening of blood clots.

• REC name

  North East - York Research Ethics Committee

• REC reference

  14/NE/1049

• Date of REC Opinion

  17 Jul 2014

• REC opinion

  Favourable Opinion