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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.

The study will last for about 72-124 weeks depending on how long the patient will be followed before they start receiving Mim8. Once the treatment starts, the patient will receive the medicine either once a week or once a month. There will be 13-17 clinical visits. Blood will be drawn at 13 or 14 of the visits.

$75 per visit to cover travel expenses


M. Elaine Eyster
Bree Kelly - at or 717-531-0003, ext=281498
Medicine: Hematology and Medical Oncology (HERSHEY)

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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Location Contacts
Hershey, PA ,