elevate
Research type
Research Study
Full title
elevate - expectations, lived experience and views of a novel factor VIII
IRAS ID
348759
Contact name
Mike Holland
Contact email
Sponsor organisation
Haemnet
Duration of Study in the UK
0 years, 7 months, 31 days
Research summary
Haemophilia A (or factor VIII (FVIII) deficiency) in its severest form mostly affects males and results in bleeding that 'just' occurs or happens afteinjury. Historically these bleeds led to early painful arthritis, immobility and disability.
Modern day treatment has focussed on replacing the missing factor to limit/prevent bleeds; even with the best adherence to treatment bleeds may still occur. Treatment involves an injection of FVIII into a vein, on average three times per week which is done by the person with haemophilia at home and can be perceived as time consuming and burdensome leading to missing/skipping doses, which may result in bleeding.
Altuvoct is a new FVIII treatment, where the FVIII has been modified so that is lasts longer in the blood, meaning that injections need only be given once a week. This will reduce treatment burden, make it easier to treat at a time that is convenient to the person with haemophilia and might improve activity and spontaneity because of less anxiety about low factor activity in the blood just before the next dose is due. With Altuvoct the level of FVIII in the blood after a week is 15iu/dl (normal is >50iu/dl) - this level is not currently achievable with other FVIII treatments.
We want to understand the impact of switching to this new treatment for people with haemophilia (or parents of children who would be treating them). We hope to understand their reasons for switching (what are their hopes and expectations) and after six months of Altuvoct use if these have been met. We will do this through two audio-recorded interviews, the first before the switch and the second approximately six months later. Each participant will act as their own 'control' as we will use their pre switch interviews hopes and expectations as a measurement of reality post switch.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
24/PR/1297
Date of REC Opinion
30 Oct 2024
REC opinion
Further Information Favourable Opinion