Prophylaxis Regimen for Hemophilia A Patients

Study Identifier:
21924
ClinicalTrials.gov Identifier:
EudraCT Identifier:
Sponsor:
Bayer
Collaborator:
N/A
Study Contact Information:
N/A
Recruitment Complete

Study Details

Medical Condition
  • Hemophilia A
  • Hemophilia
Study Drug
  • Biological: Damoctocog alfa-pegol is a recombinant B-domain deleted human coagulation FVIII variant site specifically conjugated with a 60 kDa, branched (30 kDa each) polyethylene glycol (PEG).
Date
Jul 2022 - Sep 2024
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 12+ 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
Dr. Akshat Jain - Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Status
N/A
Location
Orthopaedic Institute for Children
Los Angeles, California, United States, 90001
Status
N/A
Location
Loma Linda Children's Hospital
San Bernardino, California, United States, 92408
Status
N/A
Location
University of Colorado | Renal Research Office
Aurora, Colorado, United States, 80045
Status
N/A
Location
University of Miami Hospital
Miami, Florida, United States, 33136
Status
N/A
Location
Aflac Cancer and Blood Disorders Center
Atlanta, Georgia, United States, 30301
Status
N/A