A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors

  • STATUS
    Recruiting
  • End date
    Apr 11, 2025
  • participants needed
    244
  • sponsor
    Novo Nordisk A/S
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Updated on 12 April 2022
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Summary

This study is investigating how Mim8 works compared to other medicines in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used for prevention of bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII).

When and how often participants will receive Mim8 is dependent on their previous treatment - but is otherwise decided by chance. Mim8 will be injected into a skinfold on the stomach with a thin needle either once a week or once a month.

The study will last 54-124 weeks (12-29 months) depending on how long participants will be followed in run-in before they start treatment and if they continue in the follow period or transfer to an open label extension study. Participants will have 12-17 clinic visits.

Details
Condition Haemophilia A, Haemophilia A With Inhibitors
Treatment NNC0365-3769 (Mim8)
Clinical Study IdentifierNCT05053139
SponsorNovo Nordisk A/S
Last Modified on12 April 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study
Male or female with diagnosis of congenital haemophilia A of any severity based on medical records
Participants has been prescribed treatment with factor VIII concentrates or bypassing agent in the last 26 weeks prior to screening
Age above or equal to 12 years at the time of signing informed consent. (Local requirements for Japan, South Korea and Taiwan.)
Body weight above or equal to 30 kg
Applicable to participants treated with on-demand/no prophylaxis prior to enrolment: at least 5 bleeds in the last 26 weeks prior to screening visit, for which factor VIII concentrates or bypassing agent has been prescribed
Applicable to participants with FVIII activity above or equal to 1% who are on prophylactic treatment: at least 1 bleed in the last 26 weeks prior to screening visit, for which factor VIII concentrates or bypassing agent has been prescribed
Willingness and ability to comply with scheduled visits and study procedures, including the completion of diary and patient-reported outcomes questionnaires

Exclusion Criteria

Previous participation in this study. Participation is defined as signed informed consent
Participation in any clinical study 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
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 participants not included in the run-in
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. Breast feeding is allowed only during the run-in period
Any disorder, except for conditions associated with haemophilia A, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
Known or suspected hypersensitivity to study product(s), any constituents of the product or to related products
Receipt of gene therapy at any given time point
Ongoing or planned immune tolerance induction (ITI) therapy
Major surgery planned at the time of screening
Known congenital or acquired coagulation disorders other than haemophilia A
Hepatic dysfunction defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) above 3 times the upper limit combined with total bilirubin above1.5 times the upper limit measured at screening
Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below or equal to 30 ml/min/1.73 m^2 for serum creatinine measured at screening
Previous or current thromboembolic disease or events (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
Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation
Other conditions (e.g. autoimmune disease) or laboratory abnormality that may increase risk of bleeding or thrombosis as evaluated by the investigator
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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