A Study to Investigate the Course of Synovial Hypertrophy in Patients With Haemophilia A on Efanesoctocog Alfa Prophylaxis

Study Identifier:
Sobi.BIVV001-004
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Swedish Orphan Biovitrum
Collaborator:
PSI CRO
Study Contact Information:
Recruiting

Study Details

Medical Condition
  • Unmapped
  • Hemophilia
  • Hemophilia A, Congenital
Study Drug
  • Drug: Efanesoctocog alfa
Date
Dec 2024 - Dec 2026
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
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
Sobi Investigational Site
Milan, Italy
Status
Recruiting
Location
Sobi Investigational Site
Naples, Italy
Status
Recruiting
Location
Sobi Investigational Site
Rozzano, Italy
Status
Not yet recruiting
Location
Sobi Investigational Site
Oslo, Norway
Status
Recruiting
Location
Sobi Investigational Site
Barcelona, Spain
Status
Recruiting
Location
Sobi Investigational Site
Madrid, Spain
Status
Recruiting