A Study Following Males With Haemophilia A on Prophylaxis With Esperoct®

Study Identifier:
NN7088-4029
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 A
Study Drug
  • Drug: Turoctocog alfa pegol (N8-GP)
Date
Oct 2020 - Jun 2027
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: 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
AKH - Klin. Abt. f. Haematologie u. Haemostaseologie
Wien, Austria, 1090
Status
N/A
Location
UMHAT "Tsaritsa Yoanna-ISUL"
Sofia, Bulgaria, 1527
Status
N/A
Location
KBC Zagreb, Rebro, Hemofilija centar
Zagreb, Croatia, 10 000
Status
N/A
Location
FN Brno odd. hematologie
Brno, Czech Republic, 625 00
Status
N/A
Location
FN HK - IV. Interni hematologicka klinika
Hradec Kralove, Czech Republic, 500 05
Status
N/A
Location
North Estonia Medical Centre Foundation
Tallinn, Estonia, 13419
Status
N/A