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A multinational, open-label, randomised, controlled trial to investigate efficacy and safety of NNC0365-3769 (Mim8) in adults and adolescents with haemophilia A with or without inhibitors. (NN7769-4514)

This is a drug study that will examine the safety and effectiveness of once-weekly and once-monthly Mim8 treatment in adults and adolescents (age 12 years or above) with hemophilia A with or without factor VIII (FVIII) inhibitors.
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
congenital haemophilia A of any severity based on medical records
Pt in need of treatment with factor VIII or bypassing agent
Age above or equal to 12 years
Pt willing to discontinue emicizumab at screening
FVIII activity >1% on prophy: ≥1 bleed in the last 26 wks
Exclusion Criteria:
Female who is pregnant, breast-feeding or intends to become pregnant
Receipt of gene therapy at any given time point
Ongoing or planned ITI therapy
Previous or current thromboembolic disease or events
Participation in clinical trial within 30 days or 5 half-lives
Blood Disorders
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Study Locations

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Hershey, PA