Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery

Study Identifier:
GENA-23
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Octapharma
Collaborator:
N/A
Study Contact Information:
Recruiting

Study Details

Medical Condition
  • Hemophilia A
Study Drug
  • Drug: Nuwiq
Date
Sep 2025 - Feb 2027
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female
Age: 12+ years years
Requirements Information

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.

Trial Locations

Location
Status
Location
UT Health San Antonio
San Antonio, Texas, United States, 78229
Status
Recruiting
Location
Helsinki University Hospital,Coagulation Disorder Unit
Helsinki, Finland
Status
Recruiting
Location
Avenue de la République
Chambray-lès-Tours, France
Status
Recruiting
Location
CHU de Nantes Hôtel-Dieu
Nantes, France
Status
Recruiting
Location
Universitätsklinikum Bonn,Institut für Experimentelle Haematologie und Transfusionsmedizin
Bonn, Germany
Status
Recruiting
Location
Gerinnungszentrum Rhein-Ruhr
Duisburg, Germany
Status
Recruiting