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)

Bayer

Status: Active, not recruiting

Conditions: Hemophilia A

Treatments: Drug: Damoctocog alfa pegol (Jivi, BAY94-9027)

Study type: Observational

Funder types: Industry

Identifiers

NCT04091386

20748 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Enrolled in the HEM-POWR study (NCT03932201)
• Naïve to damoctocog alfa pegol prior to enrollment to HEM-POWR study
• Prescribed for prophylaxis treatment for hemophilia with damoctocog alfa pegol
• Patient is willing to wear the provided device
• Signed informed consent/assent to participate in LIFE-ACTIVE: 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

Exclusion criteria

• Hypersensitivity to any material of activity monitor (e.g. steel, rubber)
• Time gap between enrollment to HEM-POWR study and enrollment to LIFE-ACTIVE study is greater than 6 months

Trial design

7 participants in 1 patient group

Hemophilia A patients

Description:

Patients with hemophilia A who are being treated with Damoctocog alfa pegol (Jivi, BAY94-9027) in routine medical practice and are enrolled in Bayer-sponsored study NCT03932201

Treatment:

Drug: Damoctocog alfa pegol (Jivi, BAY94-9027)