Emicizumab in Patients With Acquired Hemophilia A

Study Identifier:
STUDY00013920
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
University of Washington
Collaborator:
Genentech, Inc.
Study Contact Information:
Recruiting

Study Details

Medical Condition
  • Hemophilia A, Acquired
Study Drug
  • Drug: emicizumab
Date
Aug 2022 - Jul 2025
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ 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
UCSD Hemophilia and Thrombosis Treatment Center
San Diego, California, United States, 92121
Status
Recruiting
Location
Georgetown University
Washington, District of Columbia, United States, 20007
Status
Recruiting
Location
Emory University
Atlanta, Georgia, United States, 30308
Status
Recruiting
Location
Bleeding and Clotting Disorders Institute
Peoria, Illinois, United States, 61614
Status
Recruiting
Location
Indiana Hemophilia and Thrombosis Center, Inc.
Indianapolis, Indiana, United States, 46260
Status
Recruiting
Location
Tulane University
New Orleans, Louisiana, United States, 70112-2632
Status
Recruiting