Lead-in Study to Collect Prospective Efficacy and Safety Data of Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Participants

Study Identifier:
SPK-8011-301
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Spark Therapeutics
Collaborator:
N/A
Study Contact Information:
N/A
Recruitment Complete

Study Details

Medical Condition
  • Ignored
  • Hemophilia A
  • Hemophilia
Study Drug
  • Drug: Standard of Care FVIII Replacement therapy
Date
Jan 2019 - Jun 2023
Patient Requirements
Sex: Male
Age: 18+ 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
University of California San Francisco
San Francisco, California, United States, 94117
Status
N/A
Location
University of Florida
Gainesville, Florida, United States, 32610
Status
N/A
Location
Emory University
Atlanta, Georgia, United States, 30322
Status
N/A
Location
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Status
N/A
Location
Mississippi Center for Advanced Medicine
Madison, Mississippi, United States, 39110
Status
N/A
Location
Bloodworks Northwest
Seattle, Washington, United States, 98104
Status
N/A