A study switching people with haemophilia A from emicizumab to Mim8 (Frontier 5)

• Research type

  Research Study

• Full title

  Open-label safety study in adults and adolescents with haemophilia A with and without FVIII inhibitors switching directly from emicizumab prophylaxis to NNC0365-3769 (Mim8) prophylaxis

• IRAS ID

  1007294

• Contact name

  Clinical Transparency Dept 2834

• Contact email

  clinicaltrials@novonordisk.com

• Sponsor organisation

  Novo Nordisk A/S

• Research summary

  This is an open-label phase 3b study investigating the safety of switching directly from emicizumab to Mim8 in adults and adolescents with haemophilia A with or without coagulation factor VIII (FVIII) inhibitors. In addition, the study is evaluating the device handling experience for administration of Mim8 using the DV3407-C1 pen-injector.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  23/LO/0303

• Date of REC Opinion

  30 Aug 2023

• REC opinion

  Further Information Favourable Opinion