At a glance
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A Multinational, Open-label, Randomised, Controlled Study to Investigate Efficacy and Safety of NNC0365-3769 (Mim8) in Adults and Adolescents With Haemophilia A With or Without Inhibitors
In Brief
A Phase 3 clinical trial evaluating NNC0365-3769 (Mim8) for Haemophilia A and Haemophilia A With Inhibitors. Completed, enrolled 281 participants across 163 sites in 34 countries.
Detailed Summary
This study is investigating how Mim8 works compared to other medicines in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used for prevention of bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). When and how often participants will receive Mim8 is dependent on their previous treatment - but is otherwise decided by chance. Mim8 will be injected into a skinfold on the stomach with a thin needle either once a week or once a month. The study will last 54-124 weeks (12-29 months) depending on how long participants will be followed in run-in before they start treatment and if they continue in the follow period or transfer to an open label extension study. Participants will have 12-17 clinic visits.
Study Details
Timeline
Interventions
Mim8 will be injected into a skinfold on the stomach with a thin needle either once a week or once a month.