A Phase III study of BAY 81-8973 in children with severe haemophilia A

• Research type

  Research Study

• Full title

  A multi-center Phase III uncontrolled open-label trial to evaluate safety and efficacy of BAY 81-8973 in children with severe haemophilia A under prophylaxis therapy.

• IRAS ID

  146525

• Contact name

  Russell Keenan

• Contact email

  Russell.Keenan@alderhey.nhs.uk

• Eudract number

  2010-021781-29

• Research summary

  The objective of the study is to demonstrate the safety and efficacy of treatment with BAY 81-8973 for prophylaxis and breakthrough bleeds in children with severe haemophilia A.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  14/NW/1227

• Date of REC Opinion

  6 Jan 2015

• REC opinion

  Further Information Favourable Opinion