Mim8 for Hemophilia A
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop your current medications. However, if you are using non-factor haemostatic products for bleeding prevention, you should not have used them within 6 months before joining the trial.
What data supports the effectiveness of the drug Mim8 for treating Hemophilia A?
How is the drug Mim8 different from other treatments for hemophilia A?
Mim8 is a next-generation bispecific antibody that mimics factor VIII, used for preventing bleeding in hemophilia A patients. It is unique because it can be administered subcutaneously (under the skin) and has a higher potency compared to earlier treatments, making it effective even in patients with inhibitors.12345
What is the purpose of this trial?
This trial is testing a new medicine called Mim8, which is injected under the skin to help prevent bleeding in children with haemophilia A. The study includes children with and without inhibitors. Mim8 works by aiding the blood clotting process. Mim8 is a next-generation treatment developed for regular use to prevent bleeding in hemophilia A.
Research Team
Clinical Transparency (dept. 2834)
Principal Investigator
Novo Nordisk A/S
Eligibility Criteria
This trial is for children aged 1-11 with severe haemophilia A, regardless of whether they have inhibitors. They must have used FVIII concentrate or a bypassing agent recently and be able to follow the study plan. Children can't join if they've had thromboembolic disease treatment (except certain past catheter-associated thrombosis), other coagulation disorders, conditions that increase bleeding or thrombosis risk, hepatic dysfunction, high serum creatinine levels, recent participation in another interventional study, mental incapacity or lack of parental support.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Mim8 prophylaxis for prevention of bleeds
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Mim8
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novo Nordisk A/S
Lead Sponsor
Lars Fruergaard Jørgensen
Novo Nordisk A/S
Chief Executive Officer since 2017
MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark
Martin Holst Lange
Novo Nordisk A/S
Chief Medical Officer since 2021
MD from University of Copenhagen