SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors
Study Details
- Hemophilia A With Inhibitor(s)
- Hemophilia B With Inhibitor(s)
- Drug: coagulation factor VIIa [recombinant]-jncw
- Have a diagnosis of hemophilia A or B with inhibitors.
- Be 12 years of age and older
- Be capable of understanding and willing to comply with the conditions of the protocol or have a legal guardian who is capable of understanding and complying with the conditions of the protocol
- Have read, understood, and documented written informed consent/assent
- Be able to provide medical evidence through prior medical history of previous inhibitor levels
- Be willing and able to use the ATHN mobile application or a paper diary to document BEs and medication usage
- Have a disorder of hemostasis in addition to Hemophilia A or B
- Have a known or suspected intolerance or hypersensitivity to SEVENFACT® or its ingredients
- Have a known allergy or hypersensitivity to rabbits or rabbit proteins
- Are receiving prophylactic treatment for bleeding with a drug or biologic that is not approved for this use by the FDA
- Have had implantation of an investigational medical device within the prior 6 months
- Have received an investigational drug within 30 days of the baseline visit
- Have an elective surgical procedure planned during the duration of their participation in the study\*
- Have any life-threatening disease, or other disease or condition which, in the investigator's judgment, could pose a potential hazard to the patient or interfere with study participation or study outcome (e.g., a history of non responsiveness to bypassing products or thromboembolic disease)
- Should a participant require an unplanned surgery, the participant will not be withdrawn from the study unless the investigator deems it necessary. Instead, the participant will receive standard of care treatment as determined by the attending physician. If the participant is not withdrawn from the study, the participant's participation in the study will be paused until the investigator feels it is safe for them to continue.
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.