NCT04091386

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

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hemophilia A

Interventions

Type	Name	Description
DRUG	Damoctocog alfa pegol (Jivi, BAY94-9027)	Intervention is given as part of routine medical practice

Timeline

• Start date: 2021-06-10
• Primary completion: 2024-05-07
• Completion: 2024-07-05
• First posted: 2019-09-16
• Last updated: 2025-06-15

Locations

8 sites across 7 countries: United States, Belgium, Canada, Italy, Slovenia, Spain, Taiwan