A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A

Study Identifier:
OBS17523
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Sanofi
Collaborator:
N/A
Study Contact Information:
Recruiting

Study Details

Medical Condition
  • Hemophilia A
Study Drug
  • Drug: Efanesoctocog Alfa BIVV001
Date
Jun 2023 - Jun 2028
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A - N/A 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
Banner MD Anderson Cancer Center- Site Number : 8400008
Gilbert, Arizona, United States, 85234-2165
Status
Recruiting
Location
Loma Linda University Health- Site Number : 8400015
Loma Linda, California, United States, 92354
Status
Recruiting
Location
Orthopedic Institute for Children- Site Number : 8400004
Los Angeles, California, United States, 90007
Status
Recruiting
Location
The Center for Inherited Blood Disorders- Site Number : 8400001
Orange, California, United States, 92868
Status
Recruiting
Location
University of Colorado Hemophilia and Thrombosis Center- Site Number : 8400019
Aurora, Colorado, United States, 80045-7202
Status
Recruiting
Location
William A. Shands Hospital at the University of Florida- Site Number : 8400032
Gainesville, Florida, United States, 32610-3003
Status
Recruiting