Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors
Status:
Recruiting
Trial end date:
2024-12-19
Target enrollment:
Participant gender:
Summary
This study will test how well a new medicine called concizumab works in the body of people
with haemophilia A or B without inhibitors. The purpose is to show that concizumab can
prevent bleeds in the body and is safe to use. Participants who usually only take medicine to
treat bleeds (on-demand) will be placed in one of two groups. In one group participants will
get study medicine from the start of the study. In the other group participants will continue
with their normal medicine and get study medicine after 6 months. The group will be decided
by chance. Participants who usually take medicine to prevent bleeds (prophylaxis treatment)
or who are already being treated with concizumab (study medicine) will receive the study
medicine from the start of the study. Participants will have to inject themselves with study
medicine every day under the skin. This can be done at home. The study doctor will hand out
the medicine in the form of a pen-injector. The pen-injector will contain the study medicine.
The study will last for about three years. Participants will have to come to the clinic for
up to 33 times. The time between visits will be approximately 4 weeks for the first 6 to
12months depending on the group participants are in, and approximately 8 weeks for the rest
of the study. At all visits, blood samples will be taken. Participants will be asked to
record information into an electronic diary during the study and may also be asked to wear an
activity tracker.