A Phase 3 Study of the Safety and Efficacy of Coagulation Factor VIIa (Recombinant) for the Prevention of Excessive Bleeding in Patients With Congenital Hemophilia A or B With Inhibitors to Factor VIII or IX Undergoing Elective Major Surgical Procedures SCOPE HIM

Study Identifier:
F7TG2202
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Laboratoire français de Fractionnement et de Biotechnologies
Collaborator:
N/A
Study Contact Information:
Recruiting

Study Details

Medical Condition
  • Hemophilia
Study Drug
  • Biological: Coagulation Factor VIIa (Recombinant)
Date
Jun 2024 - Jun 2025
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Male
Age: 12 - 65 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 - Orthopaedic Hemophilia Treatment Center
Los Angeles, California, United States, 90007
Status
Not yet recruiting
Location
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Status
Recruiting
Location
Tulane Univertsity School of Medecine
New Orleans, Louisiana, United States, 70112
Status
Recruiting
Location
M Health Fairview Center for bleeding and Clotting disorders
Minneapolis, Minnesota, United States, 55455
Status
Recruiting
Location
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Status
Recruiting
Location
Hospital Queen Elisabeth - Kota Kinabalu
Kota Kinabalu, Sabah Province, Malaysia, 88586
Status
Recruiting