MO42623 - Beyond The Bleed

• Research type

  Research Study

• Full title

  A MULTICENTER, OPEN-LABEL PHASE IV STUDY TO EVALUATE OVERALL HEALTH, PHYSICAL ACTIVITY, AND JOINT OUTCOMES, IN PARTICIPANTS AGED ≥ 13 AND < 70 YEARS WITH SEVERE OR MODERATE HEMOPHILIA A WITHOUT FVIII INHIBITORS ON EMICIZUMAB PROPHYLAXIS

• IRAS ID

  1004164

• Contact name

  Head of EU Product Development Regulatory

• Contact email

  global.eudract@roche.com

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2020-005092-13

• ISRCTN Number

  ISRCTN10101701

• Clinicaltrials.gov Identifier

  NCT05181618

• Research summary

  The aim of the study is to investigate the impact of emicizumab on overall health, physical activity and joint outcomes on eligible patients taking this treatment for a period of 36 months (about 3 years).

  Emicizumab is an antibody that is manufactured in a laboratory. Emicizumab copies what the clotting factor (FVIII) does in the blood and increases the ability of your blood to clot. It is used for routine prophylaxis in haemophilia A to prevent or reduce the number of bleeding episodes.

  Participants will be aged between ≥ 13 and< 70 years with severe or moderate haemophilia A without inhibitors, who have previously received prophylaxis with factor VIII (FVIII)
  
  The study will enrol up to 120 participants globally with severe or moderate haemophilia A without FVIII inhibitors, who have previously received prophylaxis with factor VIII (FVIII). It is an open label study and all participants will receive treatment with emicizumab. This is given as an injection under the skin (subcutaneous injection).
  
  There will be approximately 6 patients recruited at 2 UK sites
  
  The study is sponsored by F. Hoffmann-La Roche
  
  Research Summary; v1.0 28Feb2022

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  22/LO/0310

• Date of REC Opinion

  20 Jun 2022

• REC opinion

  Further Information Favourable Opinion