Clinical Trials Directory

Trials / Completed

CompletedNCT04953000

A Study of Standard and Individualized Prophylactic Treatment With Advate in Men and Boys With Severe Hemophilia A

Local, Multicenter, Non-interventional, Ambispective Study in Severe Hemophilia A Patients on Standard and PK-tailored Prophylaxis With Octocog Alfa (Advate®) in the Russian Federation

Status
Completed
Phase
Study type
Observational
Enrollment
94 (actual)
Sponsor
Takeda · Industry
Sex
Male
Age
Healthy volunteers
Not accepted

Summary

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.

Detailed description

Local, Multicenter, Non-interventional, Ambispective Study in Severe Hemophilia A Patients on Standard and PK-tailored Prophylaxis With Octocog Alfa (Advate®) in the Russian Federation

Conditions

Timeline

Start date
2021-08-19
Primary completion
2023-04-04
Completion
2023-04-04
First posted
2021-07-07
Last updated
2023-07-11

Locations

13 sites across 1 country: Russia

Source: ClinicalTrials.gov record NCT04953000. Inclusion in this directory is not an endorsement.