A Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis

Study Identifier:
MO42623
ClinicalTrials.gov Identifier:
EudraCT Identifier:
Sponsor:
Hoffmann-La Roche
Collaborator:
N/A
Study Contact Information:
N/A
Unmapped

Study Details

Medical Condition
  • Hemophilia A, Severe
  • Hemophilia A
Study Drug
  • Drug: Emicizumab
Date
Jun 2022 - Dec 2026
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 13 - 69 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
Orthopaedic Institute for Children
Los Angeles, California, United States, 90007
Status
N/A
Location
University of Miami
Coral Gables, Florida, United States, 33146
Status
N/A
Location
Oklahoma Children's Hospital ? Jimmy Everest Center
Oklahoma City, Oklahoma, United States, 73117
Status
N/A
Location
Hospital das Clinicas - UNICAMP
Campinas, SÃO Paulo, Brazil, 13083-878
Status
N/A
Location
Hospital das Clínicas Faculdades Médicas de Ribeirão Preto
Ribeirao Preto, SÃO Paulo, Brazil, 14051-140
Status
N/A
Location
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada, L9H 2B7
Status
N/A