A Research Study Looking at How Safe it is to Switch From Emicizumab to Mim8 in People With Haemophilia A (FRONTIER 5)

Study Identifier:
NN7769-4728
ClinicalTrials.gov Identifier:
EudraCT Identifier:
Sponsor:
Novo Nordisk A/S
Collaborator:
N/A
Study Contact Information:
N/A
Unmapped

Study Details

Medical Condition
  • Hemophilia A
  • Hemophilia A With Inhibitor(s)
Study Drug
  • Drug: NNC0365-3769 (Mim8) PPX
Date
Jun 2023 - Sep 2024
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & 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
Children's Hospital Los Angeles - Endocrinology
Los Angeles, California, United States, 90027
Status
N/A
Location
UC Denver Hemoph & Thrombo Ctr
Aurora, Colorado, United States, 80045
Status
N/A
Location
St Joseph's Children's Hospita
Tampa, Florida, United States, 33607
Status
N/A
Location
University of Iowa_Iowa City
Iowa City, Iowa, United States, 52242
Status
N/A
Location
Central Michigan University
Detroit, Michigan, United States, 48201
Status
N/A
Location
Univ Hosp Cleveland Med Ctr
Cleveland, Ohio, United States, 44106
Status
N/A