A research study looking at long-term treatment with Mim8 in people with haemophilia A (FRONTIER 4)
Research type
Research Study
Full title
Open-label, long-term safety and efficacy study of Mim8 in participants with haemophilia A with or without inhibitors
IRAS ID
1006365
Contact name
Clinical Transparency (Dept. 2834)
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2022-001081-35
Clinicaltrials.gov Identifier
Research summary
Haemophilia is a bleeding disorder that some people are born with. In people with haemophilia A the factor VIII (FVIII)
is missing or not working. FVIII is a protein that helps the blood to form clots to stop bleeding. Therefore, people with
haemophilia bleed more easily. As a FVIIIa mimetic, Mim8 mimics the function of activated coagulation FVIII and is being studied to see if it is effective in reducing bleeds and improving patients’ physical and social functioning. This study is an open label follow on study to investigate long-term safety and efficacy of Mim8 prophylaxis in participants, from age 1 to adults, with haemophilia A with or without FVIII inhibitors. The study will end in April 2028 or when Mim8 is commercially available, whichever occurs first. Mim8 will be provided as a ready-to-use-liquid in pre-filled cartridges or fixed-dose cartridge-based pen-injector, for subcutaneous administration either weekly, biweekly or monthly.REC name
London - West London & GTAC Research Ethics Committee
REC reference
22/LO/0746
Date of REC Opinion
13 Jan 2023
REC opinion
Further Information Favourable Opinion