Case and Use Scenario Study to Gain Knowledge on the User Needs for a Medical Device for Hemophilia A Monitoring
Study Details
- Hemophilia A
- Inclusion Criteria:
- Patients:
- With Hemophilia A diagnosis
- All Hemophilia A severity categories are eligible (mild, moderate, or severe)
- Aged 12 years and older
- For children aged 12 through 17 their parent must provide permission by signing the informed consent form
- Consider English their primary language (capable of communicating in English verbally and in writing)
- Capable of giving informed consent or assent
- Family member(s) of patients:
- Related to a patient with Hemophilia A (mild, moderate, or severe)
- Aged 18 years and older
- Consider English their primary language (capable of communicating in English verbally and in writing)
- Capable of giving informed consent or assent
- Healthcare professionals:
- Healthcare workers specialized in hemophilia care. (e.g. hematologists, nurse practitioners, physician assistants, nurses, and pharmacists)
- Capable of giving informed consent
- Exclusion Criteria:
- Patients:
- Without a diagnosis of Hemophilia A
- With acquired Hemophilia A
- Younger than 12 years of age
- Unable to communicate in English
- Incapable of giving consent or assent for themselves
- Specifically for the case scenario focus group
- Unwilling to consent to voice recording
- Participating in the use scenario part of the study
- Specifically for the use scenario part of the study
- Unwilling to consent to video recording
- Participating in the case scenario part of the study
- Family members:
- No relation to a patient with Hemophilia A (mild, moderate, or severe)
- Related to a patient with acquired Hemophilia A
- Younger than 18 years of age
- Unable to communicate in English
- Incapable of giving consent or assent for themselves
- Specifically for the case scenario focus group
- Unwilling to consent to voice recording
- Participating in the use scenario part of the study
- Specifically for the use scenario part of the study
- Unwilling to consent to video recording
- Participating in the case scenario part of the study
- Healthcare professionals:
- Without any prior hematological experience
- Not licensed as hematologists, nurse practitioners, physician assistants, nurses or pharmacists
- Unable to communicate in English
- Incapable of giving their consent to participate
- Specifically for the case scenario part of the study • Unwilling to consent to voice recording
- Specifically for the use scenario part of the study
- • Unwilling to consent to video recording
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.