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

Inclusion Criteria:

1. Informed consent obtained before any study-related activities. Study-relatedactivities are any procedures that are carried out as part of the study, includingactivities to determine suitability for the study.

2. Male and female participants with the diagnosis of congenital haemophilia A of anyseverity based on medical records.

3. Aged 1-11 years (both inclusive) at the time of signing informed consent.

4. For previously treated participants :

5. Participant has been prescribed treatment with FVIII concentrate or bypassingagent in the last 26 weeks prior to screening.

6. Participants with endogenous FVIII activity greater than or equal to 1%, basedon medical records, must have at least 1 treated bleed during the previous 26weeks before screening for which factor VIII concentrate or bypassing agent hasbeen prescribed (no requirements for participants with FVIII activity below 1%).

7. For previously untreated participants: a. Diagnosis of severe haemophilia A (endogenous FVIII activity below 1%) based onmedical records.

8. Child and parent/caregiver willingness and ability to comply with scheduled visitsand study procedures, including the completion of diary and patient-reportedoutcomes questionnaires.( For China mainland; assessed at the investigator'sdiscretion unless otherwise stated.)

Exclusion criteria:

1. Known or suspected hypersensitivity to trial product or related products.(For Chinamainland; assessed at the investigator's discretion unless otherwise stated.)

2. Previous participation in this study. Participation is defined as signed informedconsent.

3. Participation (i.e., signed informed consent) in any interventional clinical studywith receipt of last dose within 6 months (or 5 half-lives of the investigationalmedicinal product, whichever is shorter) before planned randomisation.

4. Exposure to non-factor haemostatic products for bleeding prophylaxis within 6 months (or 5 half-lives of the medicinal product, whichever is shorter) before plannedrandomisation, for participants not included in the run-in.

5. Known congenital or acquired coagulation disorders other than haemophilia A.

6. Other conditions (e.g. autoimmune disease) or laboratory abnormality that mayincrease risk of bleeding or thrombosis, as evaluated by the investigator.(For Chinamainland; assessed at the investigator's discretion unless otherwise stated.)

7. Any disorder, except for conditions associated with haemophilia A, that in theinvestigator's opinion might jeopardise the participant's safety or compliance withthe protocol.(For China mainland; assessed at the investigator's discretion unlessotherwise stated.)

8. Mental incapacity, unwillingness to cooperate or a language barrier precludingadequate understanding and cooperation.(For China mainland; assessed at theinvestigator's discretion unless otherwise stated.)

9. Lack of adequate parental/caregiver support to enter accurately and timelyinformation regarding treatment and bleeding episodes into an (electronic)diary.(For China mainland; assessed at the investigator's discretion unlessotherwise stated.)

10. Previous or current treatment for thromboembolic disease (with the exception ofprevious catheter-associated thrombosis for which anti-thrombotic treatment is notcurrently ongoing) or signs of thromboembolic disease.

11. Major surgery planned to take place after screening.(For China mainland; assessed atthe investigator's discretion unless otherwise stated.)

12. Immune tolerance induction planned to take place after treatment initiation.(ForChina mainland; assessed at the investigator's discretion unless otherwise stated.)

13. Hepatic dysfunction defined as aspartate aminotransferase (AST) and/or alanineaminotransferase (ALT) greater than 3 times the upper limit of normal combined withtotal bilirubin greater than 1.5 times the upper limit of normal measured atscreening.

14. Serum creatinine above 1.5 x upper limit of normal (ULN), measured at screening.

15. Pregnancy (female participants).(Will be assessed at investigator's discretion,according to suspicion of pregnancy.)