A Study to Learn How Safe the Study Treatment BAY94-9027 is and How it Affects the Body in Previously Treated Children Aged 7 to Less Than 12 Years With Severe Hemophilia A, a Genetic Bleeding Disorder That is Caused by the Lack of a Protein Called Clotting Factor 8 (FVIII) in the Blood

Study Identifier:
21824
ClinicalTrials.gov Identifier:
EudraCT Identifier:
Sponsor:
Bayer
Collaborator:
N/A
Study Contact Information:
N/A
Unmapped

Study Details

Medical Condition
  • Ignored
  • Hemophilia
  • Hemophilia A
Study Drug
  • Biological: Damoctocog alfa pegol (Jivi, BAY94-9027)
Date
Mar 2022 - Jan 2024
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Male
Age: 7 - 11 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
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
Status
N/A
Location
Hospital de Niños Sor María Ludovica
La Plata, Buenos Aires, Argentina, 1900
Status
N/A
Location
Organizacion Medica de Investigacion (OMI)
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1015ABO
Status
N/A
Location
Instituo Hematología Arbesú
Godoy Cruz, Mendoza, Argentina, 5501
Status
N/A
Location
Instituto de Hematología Dr. Rubén Dávoli
Rosario, Santa Fe, Argentina, S2000CKF
Status
N/A
Location
HEMORIO
Rio de Janeiro, RJ, Brazil, 20211-030
Status
N/A