A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Emicizumab in Participants From Birth to 12 Months of Age With Hemophilia A Without Inhibitors

Study Identifier:
MO41787
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
Study Drug
  • Drug: Emicizumab
Date
Feb 2021 - May 2023
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 0 - 12 Months 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
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Status
N/A
Location
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Status
N/A
Location
University of Colorado Denver, Children's Hospital
Aurora, Colorado, United States, 80045
Status
N/A
Location
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
Status
N/A
Location
University of Michigan
Ann Arbor, Michigan, United States, 48109-0934
Status
N/A
Location
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Status
N/A