ADVATE/ ADYNOVI Hemophilia A Outcome Database (AHEAD)

Study Identifier:
061001
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Baxalta now part of Shire
Collaborator:
Baxalta Innovations GmbH, now part of Shire
Study Contact Information:
N/A
Recruitment Complete

Study Details

Medical Condition
  • Hemophilia A
Study Drug
  • Biological: ADVATE
  • Biological: ADYNOVI
Date
Jun 2011 - Jan 2024
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
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Status
N/A
Location
South Metropolitan Health Service trading as Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6050
Status
N/A
Location
Landes Frauen und Kinderklinik Linz (LFKK Linz)
Linz, Austria, 4017
Status
N/A
Location
Kepler Universitätsklinikum Klinik für Kinder-und Jugendheilkunde
Linz, Austria, 4020
Status
N/A
Location
Medizinische Universitaet Wien
Wien, Austria, 1090
Status
N/A
Location
Cliniques Universitaires Saint-Luc
Bruxelles, Belgium, B-1200
Status
N/A