Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors

Study Identifier:
B7841007
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Pfizer
Collaborator:
N/A
Study Contact Information:
Recruiting

Study Details

Medical Condition
  • Hemophilia A
  • Hemophilia B
Study Drug
  • Drug: PF-06741086
Date
Nov 2021 - Jul 2030
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Male
Age: 1 Year - 74 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 Iowa
Iowa City, Iowa, United States, 52242
Status
Recruiting
Location
Northwell Health HTC
New Hyde Park, New York, United States, 11040
Status
Recruiting
Location
Washington Institute for Coagulation d/b/a WACBD
Seattle, Washington, United States, 98101
Status
Recruiting
Location
Royal Children's Hospital
Melbourne, Victoria, Australia, 3052
Status
Recruiting
Location
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2B7
Status
Recruiting
Location
Hamilton Health Sciences - McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
Status
Recruiting