Acquired Hemophilia A and Autoimmunity. Study of Lymphocyte Populations and Myeloid-Derived Suppressor Cells
Study Details
- Hemophilia A
- Patient population with acquired hemophilia A:
- Adult patients with a diagnosis of acquired hemophilia A and with a social security system. Obtaining oral non-opposition from the patient to participate in the study following the submission of an information note relating to the project.
- Obtaining signed and written informed consent for biocollection consent.
- Population of Patients with constitutional hemophilia A:
- Adult patients over 50 years of age with severe or moderate constitutional hemophilia A, with no history of autoimmune disease, and with a social security system.
- Obtaining oral non-opposition from the patient to participate in the study following the submission of an information note relating to the project.
- Obtaining signed and written informed consent for biocollection consent.
- Population of control subjects:
- Adult patients, over the age of 60, without a coagulation abnormality, with no history of autoimmune disease, and with a social security system.
- Obtaining oral non-opposition from the patient to participate in the study following the submission of an information note relating to the project.
- Obtaining signed and written informed consent for biocollection consent.
- Patient population with inflammatory pathology:
- Adult patients over the age of 50 with an inflammatory pathology likely to be associated with acquired hemophilia A, and with a social security system.
- Obtaining oral non-opposition from the patient to participate in the study following the submission of an information note relating to the project.
- Obtaining signed and written informed consent for biocollection consent.
- For the 4 groups:
- Minor patient, under guardianship or curatorship.
- Pregnant and lactating women.
- Blood transfusion less than 7 days old.
- Treatment with corticosteroids in the 7 days preceding inclusion or any other immunomodulatory or immunosuppressive treatment in the 4 weeks preceding inclusion.
Protocol Summary
This study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected under the skin using a pen-injector either once every week, once every two weeks or once every month. The participants will be trained in using the pen injector. The participants can choose themselves, in collaboration with the study doctor how often they get Mim8 in this study. When the participant will get their first Mim8 injection depends on their current treatment with emicizumab. The participants will get their first Mim8 injection at Visit 2. Participants will have between 6 and 27 Mim8 injections. The total number of injections participants will have depends on their dosing frequency. The study will last for about 6-12 months. While taking part in this study, there are some restrictions about what medicine participant can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.