Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1281-9323 | Other Identifier | World Health Organization (WHO) | |
| 2022-003053-66 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0365-3769 (Mim8) PPX | Experimental | Participants will receive Mim8 prophylaxis (PPX) subcutaneous (s.c.) injection using a prefilled fixed dose DV3407-C1 pen-injector. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0365-3769 (Mim8) PPX | Drug | Participants will receive Mim8 PPX once-weekly dosing (QW), once every two weeks dosing (Q2W), or once-monthly dosing s.c. injection using a prefilled fixed dose DV3407-C1 pen-injector for 26 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment-emergent adverse events | Measured as count of events. | From Visit 2 (week 0) until week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Device handling experience using the Hemophilia Device Handling and Preference Assessment (HDHPA) questionnaire | Measured as percentage of participants. HDHPA measures device handling experience and device preference. The measure consists of 26 items that are reported individually. it is measures in units: Percentage of participants = the distribution of participant answers within each response category, for each of the 26 individual items. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles - Endocrinology | Los Angeles | California | 90027 | United States | ||
| UC Davis Medical Center |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Visit 8 (after 26 weeks of treatment) |
| Change in participants' treatment burden using the Hemophilia treatment experience measure (Hemo-TEM) total score | Measured as score points. Hemo-TEM measures treatment burden. The measure consists of 26 items yielding 5 domain scores and 1 total score. Domain scores (score range): Injection difficulties (0-100), physical impact (0-100), treatment bother (0-100), interference with daily life (0-100), and emotional impact (0-100). Total score ranges 0-100. Higher scores indicate greater treatment burden. | From Visit 2 (week 0) until end of treatment (up to 26 weeks) |
| Sacramento |
| California |
| 95817 |
| United States |
| UC Denver Hemoph & Thrombo Ctr | Aurora | Colorado | 80045 | United States |
| St Joseph's Hospital Foundation | Tampa | Florida | 33607 | United States |
| Augusta Univ/Childrens Hosp-GA | Augusta | Georgia | 30912 | United States |
| Rush University Med. Cntr | Chicago | Illinois | 60612 | United States |
| University of Iowa_Iowa City | Iowa City | Iowa | 52242 | United States |
| Central Michigan University | Detroit | Michigan | 48201 | United States |
| Michigan State University | East Lansing | Michigan | 48824 | United States |
| Univ Hosp Cleveland Med Ctr | Cleveland | Ohio | 44106 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Penn State MS Hershey Med Ctr | Hershey | Pennsylvania | 17033-2360 | United States |
| Vanderbilt U Med Ctr_Nashville | Nashville | Tennessee | 37212 | United States |
| Universitätsklinik für Innere Medizin V | Innsbruck | 6020 | Austria |
| AKH - Klin. Abt. f. Haematologie u. Haemostaseologie | Vienna | 1090 | Austria |
| Cliniques universitaires Saint-Luc - Service Hématologie | Brussels | 1200 | Belgium |
| McMaster University | Hamilton | Ontario | L8N 3Z5 | Canada |
| Hospices Civils de Lyon- Hopital Louis Pradel-1 | Bron | 69500 | France |
| Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain | Berlin | 10249 | Germany |
| Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie | Bonn | 53127 | Germany |
| AOU Careggi Firenze | Florence | Tuscany | 50134 | Italy |
| Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| Azienda Ospedaliera di Rilievo Nazionale Santobono Pausilipon | Naples | 80122 | Italy |
| Azienda Ospedaliera Santobono Pausilipon - U.S.D. Centro Regionale Pediatrico Malattie della Coagulazione | Naples | 80122 | Italy |
| Nara Medical University Hospital_Pediatrics | Nara | 634-8522 | Japan |
| Charlotte Maxeke Johannesburg Academic Hospital | Parktown, Johannesburg | Gauteng | 2193 | South Africa |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Kyung Hee University Hospital at Gangdong | Seoul | 05278 | South Korea |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Regional Universitario de Málaga | Málaga | 29010 | Spain |
| Belfast City Hospital | Belfast | BT9 78B | United Kingdom |
| Birmingham Children's Hospital | Birmingham | United Kingdom |
| Arthur Bloom Haemophilia Centre | Cardiff | CF14 4XW | United Kingdom |
| Royal Free Haemophilia Comprehensive Care Center | London | NW3 2QG | United Kingdom |
| Royal Free Haemophilia Comprehensive Care Centre | London | NW3 2QG | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | S10 2JF | United Kingdom |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| C080406 | protein phosphatase 4 |
Not provided
Not provided
Not provided