Post-marketing Surveillance (Use Result Surveillance) With Refixia®

Study Identifier:
NN7999-4404
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Novo Nordisk A/S
Collaborator:
N/A
Study Contact Information:
N/A
Recruiting

Study Details

Medical Condition
  • Hemophilia B
Study Drug
  • Drug: Refixia®
Date
Aug 2019 - Sep 2025
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A - N/A 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
Novo Nordisk Investigational Site
Søborg, Denmark
Status
N/A
Location
Nagoya University Hospital_Blood Transfusion
Aichi, Japan, 466-8560
Status
N/A
Location
Chiba University Hospital_Diabetes, Metabolism and Endocrinology
Chiba-shi, Chiba, Japan, 260-8677
Status
N/A
Location
Hyogo prefectural kobe children's hospital
Hyogo, Japan, 654-0047
Status
N/A
Location
Tokyo Medical University Ibaraki Medical Center_Ibaraki
Ibaraki, Japan, 300-0395
Status
N/A
Location
St. Marianna University School of Medicine Hospital_Pediatrics
Kanagawa, Japan, 216-8511
Status
N/A