SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors

Study Identifier:
ATHN 16
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
American Thrombosis and Hemostasis Network
Collaborator:
LFB USA, Inc.
Study Contact Information:
Recruiting

Study Details

Medical Condition
  • Hemophilia A With Inhibitor(s)
  • Hemophilia B With Inhibitor(s)
Study Drug
  • Drug: coagulation factor VIIa [recombinant]-jncw
Date
Jun 2021 - Sep 2026
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 12 - 100 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
Arizona Hemophilia and Thrombosis Center at Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Status
Completed
Location
Arkansas Center for Bleeding Disorders
Little Rock, Arkansas, United States, 72202
Status
Recruiting
Location
Orthopaedic Institute for Children
Los Angeles, California, United States, 90007
Status
Recruiting
Location
University of California at Davis UC Davis Hemostasis and Thrombosis Center
Sacramento, California, United States, 95817
Status
Recruiting
Location
Children's National Hemophilia Center
Washington, District of Columbia, United States, 20010
Status
Recruiting
Location
Arnold Palmer Hospital for Children - The Haley Center for Children's Cancer and Blood Disorders
Orlando, Florida, United States, 32806
Status
Completed