A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia

Study Identifier:
EFC17574
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Sanofi
Collaborator:
N/A
Study Contact Information:
N/A
Unmapped

Study Details

Medical Condition
  • Hemophilia
Study Drug
  • Drug: Fitusiran
  • Drug: Clotting factor concentrates (CFC) or bypassing agents (BPA)
  • Drug: Antithrombin concentrate (ATIIIC)
Date
Feb 2023 - Sep 2026
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Male
Age: 12+ 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
Center for Inherited Blood Disorders (CIBD) Site Number : 8400012
Orange, California, United States, 92868-4306
Status
N/A
Location
University of California San Diego Site Number : 8400011
San Diego, California, United States, 92121
Status
N/A
Location
University of Minnesota Site Number : 8400016
Minneapolis, Minnesota, United States, 55454
Status
N/A
Location
Hackensack University Site Number : 8400009
Hackensack, New Jersey, United States, 07601
Status
N/A
Location
Northwell Health Hemostasis and Thrombosis Center Site Number : 8400015
New Hyde Park, New York, United States, 11040
Status
N/A
Location
University Hospitals of Cleveland Site Number : 8400001
Cleveland, Ohio, United States, 44106
Status
N/A