A Post Approval Commitment Study to Gain More Information on How Safe and Effective KOVALTRY is in Chinese Children, Adolescents /Adults With Severe Hemophilia A

Study Identifier:
19855
ClinicalTrials.gov Identifier:
EudraCT Identifier:
Sponsor:
Bayer
Collaborator:
N/A
Study Contact Information:
Recruiting

Study Details

Medical Condition
  • Hemophilia A
Study Drug
  • Biological: Recombinant Factor VIII (Kovaltry, BAY81-8973) Treatment Group 1
  • Biological: Recombinant Factor VIII (Kovaltry, BAY81-8973) Treatment Group 2
  • Biological: Recombinant Factor VIII (Kovaltry, BAY81-8973) Treatment Group 3
Date
Sep 2020 - Sep 2028
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Male
Age: 0 - 65 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
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Status
Withdrawn
Location
Shenzhen Children's Hospital
Shenzhen, Guangdong, China, 518017
Status
Not yet recruiting
Location
Shijiazhuang General Hospital
Shijiazhuang, Hebei, China, 050000
Status
Completed
Location
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
Nanjing, Jiangsu, China, 210008
Status
Completed
Location
1st Affiliated hospital of Soochow University
Suzhou, Jiangsu, China, 215000
Status
Completed
Location
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China, 330006
Status
Completed