Observational research program in Immune Tolerance Induction (ITI) v2

• Research type

  Research Study

• Full title

  An observational research project to investigate the success rate of immune tolerance Induction (ITI) after individual concentrate selection and (high-dose) treatment

• IRAS ID

  159923

• Contact name

  Rukhsana Shaikh-Zaidi

• Contact email

  rukhsana.shaikhzaidi@bpl.co.uk

• Clinicaltrials.gov Identifier

  NCT02207894

• Clinicaltrials.gov Identifier

  R29065/CN724, Oxford Hospitals NHS trust reference

• Research summary

  Observational study to evaluate the success of Immune Tolerance Induction (ITI) in 300 haemophilia A patients with newly developed or already existing Factor VIII inhibitors. ITI involves high-dose therapy with Factor VIII concentrates. Data on 200 participants will be collected prospectively (patient who still require ITI treatment) and 100 retrospectively (patients who have already been treated with ITI).

  In the UK participants in the prospective part of the study will have standard bloods taken to monitor ITI, no additional blood samples will be taken.

• REC name

  South West - Frenchay Research Ethics Committee

• REC reference

  14/SW/1092

• Date of REC Opinion

  25 Sep 2014

• REC opinion

  Further Information Favourable Opinion