A Study to Evaluate Prospective Efficacy and Safety Data of Current FIX Prophylaxis Replacement Therapy in Adult Hemophilia B Subjects (FIX:C≤2%) or Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Subjects (FVIII:C≤1%)

Study Identifier:
C0371004
ClinicalTrials.gov Identifier:
NCT03587116
EudraCT Identifier:
2017-001271-23
Sponsor:
Pfizer
Collaborator:
N/A
Study Contact Information:
N/A
Unmapped

Study Details

Medical Condition
  • Hemophilia B
  • Hemophilia A
Study Drug
  • Drug: Standard of Care FIX Replacement therapy
  • Drug: Standard of Care FVIII Replacement therapy
Date
Jul 2018 - Oct 2024
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Male
Age: 18 - 64 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
Clinical and Translational Research Unit (CTRU)
Palo Alto, California, United States, 94304
Status
N/A
Location
Lucile Packard Childrens Hospital
Palo Alto, California, United States, 94304
Status
N/A
Location
University of California, San Francisco - Outpatient Hematology Clinic
San Francisco, California, United States, 94143
Status
N/A
Location
Stanford Health Care
Stanford, California, United States, 94305
Status
N/A
Location
Hemophilia and Thrombosis Center at the University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Status
N/A
Location
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Status
N/A