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Study to Learn More About the Physical Activity Level of Patients Suffering From Hemophilia A Treated With Damoctocog Alfa Pegol (LIFE ACTIVE Study) — LIFE-ACTIVE  

Hemophilia A Clinical Trial

Official title:
Observational Study Evaluating the Physical Activity in a Subset of Damoctocog Alfa Pegol Treated Hemophilia A Patients Who Are Enrolled in the HEM-POWR Study.

Clinical Trial Summary

In this study researcher want to learn more about the change of physical activity of hemophilia A patients treated with damoctocog alfa pegol. Patients enrolled in this study will be wearing a small device measuring daily active time. Researcher will compare these physical activity data with patient's clinical data including bleeding events to gain information on how bleeding levels are related to the activity level of the patients. The study aims to enroll about 80 patients who are at the same time also participating in the HEM-POWR study (NCT03932201) evaluating the effectiveness and safety of damoctocog alfa pegol.

Clinical Trial Description

The primary objective is to evaluate the change in physical non-sedentary activity as measured by the ActiGraph CentrePoint Insight Watch (ActiGraph LLC, Pensacola, Florida) after 1, 2 and 3 years of treatment with damoctocog alfa pegol. Secondary objectives are to determine the - Change in intensity of physical activity, - Association between physical activities and clinical outcomes / patient-reported outcome scores/ number of bleeds, - Percentage of patients achieving WHO-recommended levels of activity - Actual wear time. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04091386
Study type Observational
Source Bayer
Contact
Status Active, not recruiting
Phase
Start date June 10, 2021
Completion date June 30, 2027
View Details
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