TAK-761-4001
Completed
A Study of Standard and Individualized Prophylactic Treatment With Advate in Men and Boys With Severe Hemophilia A
Clinicaltrials.gov
#NCT04953000Other
#MACS-2020-051901
About this clinical trial
The main aim of this study is to learn about changes in the lowest blood levels of Factor VIII in men and boys when upgraded from standard prophylaxis with Advate to individualized prophylaxis with Advate. No study medicines will be provided to participants in this study. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study. Participants will need to visit the study doctor 3 times in total during the study. During these visits, study data will be collected by the study doctor.
RU
Observational clinical trial.
At a glance
What medical conditions were being studied?
Hemophilia A
How many participants were enrolled?
94
Were placebos part of the clinical trial?
No
When was the clinical trial conducted?
Aug 2021 - Apr 2023
How long was participation in the clinical trial?
Participants will take part in this study for about 12 months.
Key requirements
Sex
Male
Age
All
Healthy volunteers?
No
Entry criteria
Boys and men of all ages can take part in this study.
Must have severe hemophilia A or moderate hemophilia A with a severe bleeding phenotype.
Must be on prophylaxis with Advate for 12 months or more.
Additional entry criteria will be discussed with the study doctor.