Study evaluating joint health in people with haemophilia A on prophylaxis with efanesoctocog alfa
Research type
Research Study
Full title
A low-interventional study to evaluate long-term effectiveness of real-world prophylactic treatment with efanesoctocog alfa on joint health in people with haemophilia A (ALTITUDE).
IRAS ID
1011038
Contact name
Carin Junestrand
Contact email
Sponsor organisation
Swedish Orphan Biovitrum AB (publ)
Clinicaltrials.gov Identifier
Research summary
This study will test how effective ALTUVOCT is in preventing bleeds and maintaining joint health. The study will also gain knowledge on using ALTUVOCT in real-life. Patients’ previous haemophilia A treatment(s) will be compared to ALTUVOCT in terms of the number of bleeds in a year, amount of drug taken per year, and the reason for the switch to ALTUVOCT. Patients will take ALTUVOCT as authorized and prescribed by their treating physician. The only additional procedures patients will have in this study are joint assessments at the annual visits. These assessments pose no more than the minimal risk or burden already established in patients’ standard care. Patients will have a blood sample taken for FVIII inhibitors (neutralizing antibodies circulating the body that that may prevent ALTUVOCT from working properly) if they do not already have an inhibitor test result in connection with the switch to ALTUVOCT. Once enrolled, patients will have yearly on-site visits for 24 months or 36 months, depending on the time of enrolment in relation to study closure.
A total of about 250 patients will be asked to join this study around the world which is planned to run to up to 5 sites in the UK.REC name
London - Brent Research Ethics Committee
REC reference
25/LO/0011
Date of REC Opinion
25 Feb 2025
REC opinion
Further Information Favourable Opinion