NCT05306418

A Research Study Looking at Mim8 in Children With Haemophilia A With or Without Inhibitors

Safety, Efficacy and Exposure of Subcutaneously Administered NNC0365-3769 (Mim8) Prophylaxis in Children With Haemophilia A With or Without FVIII Inhibitors

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 1 Year – 11 Years
• Healthy volunteers: Not accepted

Summary

This study is looking at how Mim8 works compared to other medicines in children with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used for prevention of bleeds. Mim8 will be injected with a thin needle into the skin. The study will last for about 54-98 weeks, from screening to follow-up visit, In case the participant experiences bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor.

Conditions

• Haemophilia A With or Without Inhibitors

Interventions

Type	Name	Description
DRUG	Mim8	For treatment part 1, all participants will start on once-weekly treatment and continue on this regimen until week 26. For treatment part 2, starting at week 26, all participants will be offered the choice to remain on once-weekly or switch to once-monthly dosing. Mim8 will be injected with a thin needle into the skin

Timeline

• Start date: 2022-04-04
• Primary completion: 2024-11-13
• Completion: 2024-11-13
• First posted: 2022-04-01
• Last updated: 2025-11-13

Locations

52 sites across 19 countries: United States, Canada, China, Germany, India, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Portugal, Russia, South Africa, South Korea, Spain, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study