Haemophilia is a bleeding disorder that some people are born with. People with haemophilia A lack a certain coagulation factor called FVIII. FVIII is a component of the blood that is needed to stop bleeding. Therefore, people with haemophilia bleed more easily. 
Mim8 is not the same as FVIII, but it is a medicine that replaces the function of the missing or inactivated coagulation factor in the blood of people with haemophilia A. 
We are doing this study to investigate how Mim8 works during weekly and monthly dosing in people with haemophilia A, who either have inhibitors or do not have inhibitors. Inhibitors are something that body may produce which alters or stops the effect of coagulation factor FVIII replacement medicine. 

This study will mainly look at:
•	The effects of the study medicine. This will be done by counting the number of bleeds in the study and looking at the results from the blood samples.
•	Side effects of the drug. This will be done by looking at the results of the blood samples and general health during the study.
•	Any improvements in how the subject feel in daily life when taking study medicine. This will be done by asking subject to fill in some questionnaires about the subject's health.

Prevention

•	If the subject has not had prophylaxis before the study, the subject will get Mim8 once a week for 26 weeks (Arm 1) or for 52 weeks (Arm 2). 
•	If the subject has had prophylaxis before the study, the subject will get Mim8 once a week (Arm 3) or once a month (Arm 4) for 52 weeks.

Arm Label

Target Number of Participant

Arm Type

Arm Description

If the subject has not had prophylaxis before the study, the subject will get Mim8 once a week for 26 weeks.

Arm Label

Target Number of Participant

Arm Type

Arm Description

If the subject has not had prophylaxis before the study, the subject will get Mim8 once a week for 52 weeks.

Arm Label

Target Number of Participant

Arm Type

Arm Description

If the subject has had prophylaxis before the study, the subject will get Mim8 once a week for 52 weeks.

Arm Label

Target Number of Participant

Arm Type

Arm Description

If the subject has had prophylaxis before the study, the subject will get Mim8 once a month for 52 weeks.

Gender

Age

Description

1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
2. Male or female with diagnosis of congenital haemophilia A of any severity based on medical records
3. Patient has been prescribed, or in need of, treatment with factor VIII or bypassing agent in the last 26 weeks prior to screening 
4. Age above or equal to 12 years at the time of signing informed consent. 
5. Body weight ≥30 kg 
6. Applicable to patients treated on-demand/with no prophylaxis: ≥5 bleeds in the last 26 weeks prior to screening visit
7. Applicable to patients with FVIII activity >1% who are on prophylactic treatment: ≥1 bleed in the last 26 weeks prior to screening visit
8. Willingness and ability to comply with scheduled visits and study procedures, including the completion of diary and patient-reported outcomes questionnaires

1. Previous participation in this trial. Participation is defined as signed informed consent
2. Participation in any clinical trial of an approved or non-approved investigational medicinal product, within 30 days (or 5 half-lives of the investigational medicinal product, whichever is greater) before screening
3. Exposure to non-factor haemostatic products for bleeding prophylaxis within 6 months (or 5 half-lives of the medicinal product, whichever is shorter) prior to planned first dose, for patients not included in the run-in.
4. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method (highly effective contraceptive measures as defined in protocol Section 10.4 or as required by local regulation or practice). Breast feeding is allowed only during the run-in period
5. Any disorder, except for conditions associated with haemophilia A, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol
6. Known or suspected hypersensitivity to trial product(s), any constituents of the product or to related products
7. Receipt of gene therapy at any given time point
8. Ongoing or planned ITI therapy
9. Major surgery planned at the time of screening. For definition of major surgery see protocol Table 6 7
10. Known congenital or acquired coagulation disorders other than haemophilia A
11. Hepatic dysfunction defined as AST and/or ALT >3 times the upper limit combined with total bilirubin >1.5 times the upper limit measured at screening
12. Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) ≤30 ml/min/1.73 m2 for serum creatinine measured at screening
13. Previous or current thromboembolic disease or eventsa (with the exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or risk of thromboembolic disease, as evaluated by investigator
14. Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation
15. Other conditions (e.g. autoimmune disease) or laboratory abnormality that may increase risk of bleeding or thrombosis as evaluated by the investigator

Number of treated bleeds

From randomisation to end of main treatment

All endpoints related to subgroups of bleeds

From randomisation to end of main treatment