An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A

Study Identifier:
22991
ClinicalTrials.gov Identifier:
NCT07088458
EudraCT Identifier:
N/A
Will Be Recruiting

Study Details

Medical Condition
  • Hemophilia A
Study Drug
  • Drug: Damoctocog alfa pegol (Jivi, Bay94-9027)
Date
Apr 2026 - Dec 2029
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 7 - 12 Years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Diagnosis of hemophilia A
  • Patients must be 7 to \< 12 years of age at enrollment
  • Patients previously treated for hemophilia A ((≥50 exposure days to FVIII)
  • No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor
  • Patients without a previous history of inhibitors or patients with a previous history of inhibitors on standard prophylaxis therapy for at least 1 year prior to study entry
  • Initiation of prescription or currently prescribed damoctocog alfa pegol for regular continuous prophylaxis (intent to treat for 52 weeks/year)
  • Signed informed consent/assent.
Exclusion Criteria
  • Presence of a FVIII inhibitor
  • Concurrent participation in an investigational program with interventions outside of routine clinical practice
  • Diagnosis of any other bleeding/coagulation disorder other than hemophilia A
  • Use of another hemostatic agent as the primary method of bleeding prophylaxis during the observation period
  • Contra-indications according to the local marketing authorization
  • Current immune tolerance induction (ITI) treatment for a FVIII inhibitor

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

No locations found.